Child Health and Human Development Extramural Research

 

To conduct and support laboratory research, clinical trials, and studies with people that explore health processes. NICHD researchers examine growth and development, biologic and reproductive functions, behavior patterns, and population dynamics to protect and maintain the health of all people. To examine the impact of disabilities, diseases, and defects on the lives of individuals. With this information, the NICHD hopes to restore, increase, and maximize the capabilities of people affected by disease and injury. To sponsor training programs for scientists, doctors, and researchers to ensure that NICHD research can continue. By training these professionals in the latest research methods and technologies, the NICHD will be able to conduct its research and make health research progress until all children, adults, families, and populations enjoy good health. The mission of the NICHD is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation.

Active 93.865 National Institutes of Health, Department of Health and Human Services B - Project Grants Fiscal Year 2016 Post third quarter reallocation: Fiscal year 2016 competing and noncompeting research project grants estimates are 1,567. Of this number, 85 are expected to be SBIR/ STTR awards. Approximately 50 research centers will be awarded. A planned 462 other research grants are anticipated to be awarded. Projected institutional training awards are 489 in fiscal year 2016. The individual training award are projected for fiscal year 2016 to be 114. Fiscal Year 2016: Fiscal year 2016 competing and noncompeting research project grants actuals were 1,551. Of this number, 87 were SBIR/ STTR awards. A total of 50 research centers were awarded. 450 other research grants were also awarded. There were institutional training grants to support 476 trainees that were awarded in fiscal year 2016. The individual training awards were 109 for fiscal year 2016.
Fiscal Year 2017 Budget Actuals: Fiscal year 2017 competing and noncompeting research project grants actuals were 1,655. Of this number, 86 were for SBIR/ STTR awards. Exactly 49 research centers were awarded. A total of 401 other research grants were awarded. There were institutional training grants support provided for 439 trainees in fiscal year 2017. The individual training awards for fiscal year 2017 were 132.
Fiscal Year 2018 Budget Estimate: Fiscal year 2018 competing and noncompeting research project grants actual awards were 1,805. Of this number, 107 were SBIR/ STTR awards. Precisely 51 research centers were awarded. A total of 418 other research grants were awarded. There were institutional training grants that supported 423 trainees that were awarded in fiscal year 2018. The individual training award for fiscal year 2018 were 174.
Fiscal Year 2019 Budget Request: Fiscal year 2019 competing and noncompeting research project grants estimates are 1,891. Of this number, 111 are expected to be SBIR/ STTR awards. Approximately 52 research centers will be awarded. A planned 412 other research grants are anticipated to be awarded. There are projected institutional training grants to support 422 trainees that are planned to be awarded in fiscal year 2019. The individual training award are projected for fiscal year 2019 to be 224.
Fiscal Year 2020 Budget Request: Fiscal year 2020 competing and noncompeting research project grants estimates are 1,753. Of this number, 93 are expected to be SBIR/ STTR awards. Approximately 42 research centers will be awarded. A planned 353 other research grants are anticipated to be awarded. There are projected institutional training grants to support 394 trainees that are planned to be awarded in fiscal year 2020. The individual training award are projected for fiscal year 2020 to be 191. Public Health Service Act, Section 301, 448 and 487, as amended, Public Laws 78-410 and 99-158, as amended, 42 U.S.C. 241; 42 U.S.C. 285g; 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564, Public Law 115-245 Universities, colleges, medical, dental and nursing schools, schools of public health, laboratories, hospitals, State and local health departments, other public or private institutions, both nonprofit and for-profit, and individuals. National Research Service Award: Support is provided for academic and research training only, in health and health-related areas that are periodically specified by the National Institutes of Health. Individuals with a professional or scientific degree are eligible (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree). Predoctoral research training grants to institutions are also supported. Proposed study must result in biomedical or behavioral research training in a specified shortage area and which may offer opportunity to research health scientists, research clinicians, etc., to broaden their scientific background or to extend their potential for research in health-related areas. Applicants must be citizens of the United States or be admitted to the United States for permanent residency; they also must be nominated and sponsored by a public or private institution having staff and facilities suitable to the proposed research training. Domestic nonprofit organizations may apply for the institutional NRS grant. SBIR: SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees). Primary employment (more than one- half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. or its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. Any nonprofit or for-profit organization, company, or institution engaged in biomedical or biobehavioral research. Applicants should submit electronically via Grants.gov as directed in the relevant NIH Funding Opportunity Announcement. All required forms specified in the application kit are to be completed by the applicant and submitted with the application package. National Research Service Award: Individual Award: The applicant's academic record, research experience, citizenship, and institution sponsorship should be documented in the application. Institutional Award: the applicant organization must show the objectives, methodology, and resources for the research training program, the qualifications and experience of directing staff, the criteria to be used in selecting individuals for awards, and a detailed budget and justification for the amount of grant funds requested. For-profit organizations' costs are determined in accordance with 48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined by HHS Regulations, 45 CFR, Part 74, Subpart Q. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Preapplication coordination is not applicable. 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. National Research Service Award: Prior to formal application, an individual must arrange for acceptance at a sponsoring institution by a sponsor who will supervise the training. Individuals must be sponsored by a domestic or foreign institution. SBIR/STTR: Same as for grants (above). Applications are submitted electronically via Grants.gov following the general guidance provided at: http://grants.nih.gov/grants/forms.htm and the specific instructions for the respective Funding Opportunities Announcement which may be found at: http://grants.nih.gov/grants/guide/index.html Each application receives a dual scientific review by non-NIH scientists. Awards are issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). National Research Service Awards: Applications are reviewed for scientific merit by an appropriate study section committee or by an institute review committee. If recommended for approval and a decision is made to make an award, a formal award notice will be sent to the applicant and sponsor. Institutional Awards are issued by the Eunice Kenney Shriver National Institute of Child Health and Human Development (NICHD). All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for the available SBIR/STTR set-aside funds on the basis of scientific and technical merit and the commercial potential of the proposed research, program relevance, and program balance among the areas of research. Contact the headquarters or regional office, as appropriate, for application deadlines, or consult the specific Funding Opportunity Announcement listed in the NIH Guide for Grants and Contracts at: https://grants.nih.gov/funding/searchGuide/nih-guide-to-grants-and-contracts.cfm. General guidance about application due dates may be found at: http://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/standard-due-dates.htm Contact the headquarters or regional location, as appropriate for application deadlines More than 180 days. From 6 to 9 months: National Research Service Awards: From 6 to 9 months. SBIR/STTR: approximately 6 months. Not applicable. More than 180 days. Renewal applications are accepted, as described in the relevant Funding Opportunity Announcement (FOA) found at: http://grants.nih.gov/grants/guide/index.html?CFID=50541572&CFTOKEN=87322295&jsessionid=f630f3b44e23db8088b9e5e5224596361271. National Research Service Awards: awards may be made for 1, 2, or 3 years. No individual may receive NIH fellowship support at the postdoctoral level for more than 3 years. Institutional Awards may be renewed. The major elements in evaluating proposals include assessments of the significance of the proposed research; approach; innovation; investigators; and environment. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Grantee agrees to administer the grant in accordance with the regulations and policies governing the research grant programs of the Public Health Service as stated in the terms and conditions on the application for the grant. National Research Service Awards: Awarded to individuals for full-time research training in specified behavioral and biomedical shortage areas. Awardees may utilize some of their time in academic and clinical duties if such work is closely related to their research training. Awards may be made to institutions to enable them to make NRS awards to individuals selected by them. Each individual awardee is obligated upon termination of the award to comply with certain service and payback provisions. SBIR Phase I grants (of approximately 6-months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of the research initiated in Phase I and which are likely to result in commercial products or processes. STTR Phase I grants (normally of 1- year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential on Phase II application. Performance Reports: The grantee institution is required to submit a progress report on an annual basis for each grant award, which includes monitoring of performance. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials. Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period. Statutory formula is not applicable to this assistance listing.

Matching requirements are not applicable to this assistance listing.

MOE requirements are not applicable to this assistance listing. Awards are usually made annually with no project period to exceed 5 years in length. National Research Service Awards: From 1 to 3 years. SBIR: Phase I awards are generally for 6 months; Phase II awards normally may not exceed 2 years. STTR Phase I awards are generally for 1 year; Phase II awards normally may not exceed 2 years. Each year, submitted progress reports for awarded grants are reviewed, and if satisfactory progress is demonstrated, a Notice of Grant Award is issued. None/Not specified. Eugene G. Hayunga,
6710-B Rockledge Drive, Room 2216
Bethesda, MD 20892-7510 US
ehayunga@mail.nih.gov
Phone: (301) 435-6856. http://www.nichd.nih.gov/Pages/index.aspx 75-0844-0-1-552 (Project Grants) FY 18$1,040,649,876.00; FY 19 est $1,083,139,000.00; FY 20 est $916,805,000.00; FY 17$979,273,038.00; FY 16$945,498,160.00; - For FY 2018, of the $1,040,649,876 for Total Research Grants, $43,151,486 was for SBIR/STTR activities and awards. For FY 2019, of the estimated $1,083,139,000 for Total Research Grants, $43,869,000 is planned for SBIR/STTR activities and awards. For FY 2020, of the estimated $916,805,000 for Total Research Grants, $37,493,000 is planned for SBIR/STTR activities and awards. For research project grants, fiscal year 2019, range is $50,000 to $5,000,000; average is $462,704. Individual research fellowship awards: Basic stipend (first year beyond the doctoral degree) of approximately $45,000. The sponsoring institution will be provided, on application, with an allowance of up to approximately $8,000 per year to help defray the cost of training. No dependency allowances. SBIR: Average Phase I awards are for approximately $225,000 (grant activity R43 - for up to six months); Phase II awards may be made for amounts up to $1,500,000 (grant activity R44 - for up to two years). 42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; NIH Grants Policy Statement, (Rev.) March 1, 2001, available on the NIH website at http://grants.nih.gov/grants/policy/nihgps_2001/; NIH Guide to Grants and Contracts, available on the NIH website at http://grants.nih.gov/grants/guide/. Grants will be available under the authority of and administered in accordance with the NIH Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications. Fiscal Year 2016 In FY 2016, NICHD will also support broad NIH scientific efforts: Pregnancy and Birth - NICHD recently announced funding to launch the Human Placenta Project, an initiative that will develop technologies to assess, in real time, the structure and function of the human placenta. Critical for both maternal and fetal health, the placenta also has substantial implications for long-term health of both mother and child. The Project’s goals include understanding normal and abnormal placental development, developing biomarkers to predict adverse pregnancy outcomes, and developing interventions to prevent abnormal placental and fetal development. The Project will also examine the effects of environmental factors, such as pollution, medications, or diet on the placenta. In the coming year, NICHD will launch “MyPregnancy,” a longitudinal, crowd-sourced, citizen science approach that gathers information about pregnancy from the experts - pregnant women. This will deepen our knowledge about what women experience physically and emotionally during pregnancy and after giving birth, the effects of pregnancy on women’s lives, the challenges pregnant women face, such as health issues related to disability or a chronic health condition, and what features are common to many pregnancies. Participants will use web-based or mobile devices to enter information via online questionnaires and will be able to print out reports to share with their health care team and view summaries of de-identified data to see how they compare to other women. MyPregnancy will also provide links to evidence-based information about pregnancy from trusted partner agencies and organizations and about other ways to participate in research about pregnancy. MyPregnancy will inform pregnant women while involving them in finding ways to improve pregnancy care. Infancy - Through the Hunter Kelly Newborn Screening Research Program, NICHD has long provided much of the evidence for determining whether a health condition can be detected in newborns, and whether it can be treated or cured. Currently, most states screen newborns for a panel of 29 conditions, thus preventing extensive disease and disability. However, the newest technologies, such as genome sequencing, raise new social and ethical questions. NICHD recently hosted a meeting to discuss the research implications of new informed consent requirements mandated by the 2014 Newborn Screening Saves Lives Act reauthorization, and is providing guidance about how to meet the law’s requirements while preserving this lifesaving research. Building on two decades of research that has helped decrease United States infant mortality rates, NICHD continues to expand its work to prevent sudden unexplained infant deaths, both through research on risk factors and a major public education campaign. Because of this ongoing research, the original “Back to Sleep” message has evolved to “Safe to Sleep,” encouraging parents and infant caregivers to create safe sleep environments throughout the day and night while continuing other health-promoting practices, such as breastfeeding. NICHD is supporting particular outreach efforts to tailor culturally sensitive messages to underserved populations. Pediatric Development and Rehabilitation from Injury - NICHD studies of brain development shed light on how human brains function, including insights into abnormal function, so that effective interventions can be developed. One new study found that overweight or obese children are slower than children of healthy weight to recognize when they have made an error, and are slower to correct that error. Although the effects of childhood obesity on later chronic health conditions has been well documented, this is one of the first studies to show that being overweight can affect how well a child organizes and prioritizes thoughts. Other NICHD-funded researchers used new technologies to track myelination, the development of the brain’s “white matter,” in children from kindergarten through third grade. The developmental course of the children’s white matter predicted ability to read, raising the possibility that this method could be used to diagnose children with dyslexia and other reading disorders before they experience problems in school. Understanding human development in adolescence, with its substantial physical, mental, and behavioral changes, poses a particular challenge. While many programs encourage physical activity, concerns have arisen about the long-term effects of activity-related traumatic brain injury (TBI) in young people, who often quickly recover basic intellectual functioning and learning ability, but may have longer-term trouble with complex tasks, such as schoolwork, driving, or social interactions. Recently, NICHD-funded researchers developed a way to shorten TBI recovery time through “gist training,” which helps young people extract the fundamental meaning of a conversation or article while leaving out the details, a skill basic to everyday functioning. Individuals with Special Needs - NICHD has long supported research on intellectual and developmental disabilities, and on developing therapies for these conditions. With the support of the trans-NIH Down Syndrome Working Group and the public-private Down Syndrome Consortium, NICHD launched DS-Connect™: The Down Syndrome Registry. DS-Connect™, now including 2,800 registrants, is a web-based, voluntary, secure health registry that provides anonymized information to families and clinicians. This year, DS-Connect™ added a special subsite for researchers and health care professionals. Researchers may sign up for free access to de-identified data, or work with the registry coordinator to find participants for clinical trials, to help increase our understanding of Down syndrome and how to treat its accompanying health issues across the lifespan. Embracing Research Opportunities - Increasingly, researchers need to work in transdisciplinary teams, manage massive amounts of data, and acquire new and diverse skill sets. Therefore, NICHD is establishing a new publicly accessible, online data and specimen hub to enable sharing of data and biospecimens from NICHD-supported studies. This archive will maximize use of research findings, not only for the original study purposes, but through secondary analyses as well. We expect to add data from eight to ten studies a year, eventually creating a rich information source for the entire research community. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) supports a broad research portfolio uniquely focused on human health and development, from before birth through adulthood. In scientific domains encompassing developmental biology, reproductive health, pediatrics, population sciences, and medical rehabilitation, NICHD supports research that helps us better understand how health and disease develop over time, to prevent, reduce and treat illness and disability in current and future generations. The lifelong process of human development is shaped by an array of complex physiological processes that interact with behavioral, social, and environmental factors. Fundamental scientific knowledge about how these processes work may not yield commercially-viable new treatments quickly – or at all. Yet fundamental research is the foundation of medical progress. Basic research helps identify crucial points in the disease process for treatment or prevention; reveals new compounds for testing as candidate therapies; pinpoints previously unsuspected risk factors for multiple conditions; and generates new approaches to prevention and cure. NICHD’s support for fundamental science emphasizes technologies and tools to understand both normal development and disease, as well as creating new ways to measure progress in improving health. NICHD actively promotes data sharing and supports publicly-available databases and biobanks to help ensure that relevant materials are available for translational research in maternal, pediatric, and reproductive health. NICHD’s continuing efforts to understand the crucial role of the human placenta has already begun to provide an unprecedented wealth of information on how placental function affects maternal and fetal health. NICHD also continues to prioritize continuing investment in basic and translational research related to structural birth defects, which are a major cause of infant death in the United States. Populations of primary interest to NICHD -- children, pregnant women, and persons with physical and intellectual disabilities – have too often and for too long been prescribed drugs, devices, and other treatments that were designed for and tested in groups from which they differ physiologically. Parents, pregnant women, individuals with disabilities, and their health care providers are often put in an extremely difficult position in which they have little or no information to assess whether the treatment is more dangerous than the disease. NICHD supports clinical research that specifically focuses on these populations, in the real-world settings where they receive treatment—including neonatal and pediatric intensive care units; fertility, rehabilitation, and HIV clinics; day care and schools; and physicians’ offices. For example, the neonatal intensive care units across the United States that form NICHD’s Neonatal Research Network are currently conducting clinical trials on potential treatments for neonatal sepsis, necrotizing enterocolitis, and anemia to help the smallest and most vulnerable infants. The Zika in Infants and Pregnancy (ZIP) study intends to enroll 10,000 pregnant women in areas where Zika virus is prevalent, including Puerto Rico, Brazil, and Colombia. Continuing this line of research will allow scientists to obtain data on the developmental effects of the virus on children, including understanding the relationship btween timing of exposure and development of microcephaly. This will help clinicians, parents, and educators to better support children affected by prenatal exposure to Zika. Fundamental biomedical and behavioral science is essential to prevention and health promotion. Recent scientific findings show that pregnancy is a “stress test” that indicates a higher risk for more serious problems as women age. For example, NICHD-supported research has shown that women with pregnancy complications such as preeclampsia and gestational diabetes have a higher risk of developing heart disease and type 2 diabetes later in life. NICHD research has also demonstrated that lifestyle factors such as nutrition and exercise can mitigate these risks. Physical activity is a key component to maintaining physical health and decreasing secondary health conditions throughout life. However, individuals with disability experience a number of physical, social, and environmental barriers that make it more difficult for them to participate in physical activity. NICHD’s National Center for Medical Rehabilitation Research (NCMRR) studies interventions that can promote, monitor, and sustain physical activity programs for people with disabilities in real-world settings (e.g., home, community, workplace, and school). This includes the use of engineering and social-science approaches to understand the effect of environmental factors, monitor individual participation, and promote overall health and independence. NICHD continues to prioritize funding for new and early-stage investigators, to ensure that there is a pipeline of scientists and clinicians who are focused on the health problems of the communities NICHD serves, and to make certain that scientific progress continues to the next generation. Over the past two years NICHD has convened a Training Task Force that has examined outcomes for a variety of different training pathways. NICHD will use the evidence gathered from the Task Force’s analysis to preferentially fund mechanisms that require individuals, rather than institutions, to apply for training opportunities. The broad scientific opportunities at NICHD come with the recognition that thoughtful prioritization and careful stewardship are essential. NICHD has implemented data-driven approaches to portfolio analysis, program evaluation, and performance assessment. This will help the Institute make strategic funding choices, focusing on areas that hold the most promise to improve the health of children, pregnant women, individuals with disabilities, families, and communities. Through a visioning process that has occurred over the past several years, NICHD has identified scientific research priorities that have been shared with the research community and the public. NICHD will use these priorities to identify key areas for continued support.
Fiscal Year 2019 Reproductive Health, Pregnancy, and Perinatology The program in reproductive health, pregnancy, and perinatology supports basic, clinical, and translational research on gynecologic disorders, fertility and infertility, pregnancy, and newborn care. NICHD manages a broad research portfolio to understand, treat, and prevent common, painful, and costly reproductive health conditions, including uterine fibroids, vulvodynia, pelvic floor disorders, and endometriosis. For example, scientists recently compared two minimally invasive uterine fibroid procedures to assess their advantages and disadvantages from a patient perspective. Women undergoing one procedure reported experiencing more post-procedure pain, using more prescription medications, and having longer total recovery times. In addition, the other procedure had a shorter treatment time, often requiring only one visit. Millions of couples across the United States have difficulty conceiving or carrying a child, yet only limited information is available to understand the causes of infertility, minimize risk factors, and improve treatment options. For example, although there has been little research to support their use, tests to predict ovarian reserve (the number of a woman’s remaining eggs before menopause) are routinely offered in many fertility clinics on the assumption that women with a lower ovarian reserve would be less likely to respond to treatment. However, researchers supported by both NICHD and the National Institute of Environmental Health Sciences (NIEHS) recently found that these tests do not appear to predict the short-term probability of conception among women from 30 to 44 years of age. NICHD-funded research is helping to save infants' lives not only in the United States but also around the world. Recently, NICHD-supported researchers demonstrated that daily doses of beneficial bacteria, or probiotics, reduced the rate of sepsis—a life-threatening infection of the bloodstream—among newborns in India by 40 percent. The study is the first to show that probiotics therapy can prevent disease on a large scale, which could provide an inexpensive and effective way to reduce serious, widespread infection among newborns in developing countries. NICHD supports prevention research to help reduce rates of high-risk pregnancies and preterm birth, as well as the associated lifelong morbidities for mother and child. Preeclampsia, for example, is a dangerous condition that leads to high blood pressure in pregnant women, and can cause maternal mortality. It is a major cause of preterm birth, and is associated with long-term risk of heart disease in women. NICHD-supported scientists visualized and isolated individual cells of four different types in placental tissue from women who had had preterm births or severe preeclampsia, and subsequently compared the RNA molecules that the various cell types produced. In the placentas from women with preeclampsia, the researchers found abnormal levels of RNA molecules associated with immune function, cell growth, cell movement, hormone response, growth factors, formation of blood vessels, and molecular transport. These differences provide clues about molecular changes and altered cell functions associated with preeclampsia. In the future, developing new tests for these changes might help identify pregnant women who are at greater risk for this serious condition. Child Health Research on child health explores basic biological processes that control healthy or atypical development, translational research from the bench to the bedside, behavioral and social science research, and clinical studies in pediatric pharmacology, infectious diseases, nutrition, endocrinology, trauma and critical illness, and other aspects of pediatric medicine. NICHD’s basic research portfolio on developmental biology has led to a better understanding of normal embryonic development, as well as mechanisms that underlie causes of structural and functional birth defects. For example, 22q11.2 deletion syndrome is a rare disorder that occurs when a small portion of chromosome 22 is missing. Individuals with 22q11.2 deletion syndrome may experience a variety of symptoms, including intellectual disability, psychiatric disorders, and defects in the kidney and urinary tract systems. Scientists studied the genetic makeup of over 2,000 patients with kidney and urinary tract anomalies, compared to over 22,000 control subjects. The researchers found a particular gene that was missing. The researchers then used zebrafish and mouse models to show how this gene plays an important role in urinary tract development, pinpointing dysfunctional processes and ultimately paving the way for new treatments that may benefit both patients with 22q11.2 syndrome and other kidney conditions. NICHD supports and conducts domestic and international research related to the epidemiology, diagnosis, clinical manifestations, pathogenesis, transmission, treatment, and prevention of HIV infection, its complications, and other significant infectious diseases in infants, children, adolescents, and pregnant and non-pregnant women. Based on NICHD’s initial work, current treatment regimens have all but eliminated HIV transmission from women to their offspring in the United States. However, children and youth who are infected must still take medications daily to control the virus. Many in this group have now reached adolescence or young adulthood and are transitioning into adult care. Researchers studied over 1,400 youth at different ages (7-12 years old, 13-17 years old, and 18-30 years old) who were infected with HIV at birth, measuring the participants’ immune systems and amount of virus in their bodies. Over the following five-year period, the participants’ immune systems declined, amount of viral load increased, and they became sicker. These findings suggest that healthcare providers need new ways to provide better, continuous care for these young people as they become young adults. Because children and infants differ physiologically from adults, medications developed and tested in adults often work differently in children. For example, health care providers often use combined antibiotics, such as piperacillin-tazobactam, to treat hospital-acquired severe infections in newborns. This combination is relatively safe in adults, but its effects on infants are unclear. Measuring the level of antibiotics in the blood provides information on exposure and clearance of the antibiotic from the baby. This is essential to determine the medication’s relative safety. However, the small circulating blood volume in a baby makes measuring these levels difficult. Researchers examined data from over 700 infants who received piperacillin-tazobactam while hospitalized, used a mathematical model to simulate how the antibiotics were processed by the infants, and examined hospital medical records for adverse reactions. Their findings supported the safety of these antibiotics for infants. NICHD's child health program also supports research on child maltreatment and associated interventions. Child maltreatment may have lifelong effects, but removal from the abusive environment may also have negative effects. Researchers compared a home-visit program that videotaped parent-child interactions, reviewed the footage, and coached parents to become more sensitive to their child’s social and emotional cues, with a telephone-based service and packets of information. Parents who received the video intervention scored higher on measures of engagement and sensitivity, compared to parents who received the telephone-based service. Foster care placements also were lower by more than double among parents who received the home-based intervention. Training and career development efforts are crucial for sustaining the child health research workforce. NICHD brings young scientists into pediatric research, including physician-scientists, behavioral and social science researchers, and basic scientists, through both individual and institutional training programs. In addition, loan repayment programs for pediatric research are an important mechanism for retaining clinical scientists in research careers. NICHD’s efforts to support science training begin early in the career pipeline, including programs to enhance developmental biology research training for undergraduates. Former postdoctoral trainees from NICHD’s pediatrics training programs are now researching ways to help children with learning disabilities, identify genetic causes of specific rare birth defects, and improve treatment for preterm babies. Intellectual and Developmental Disabilities Part of NICHD’s legislative mandate is to encourage investigations of human development throughout the lifespan, with an emphasis on understanding intellectual and developmental disabilities (IDDs). The program on IDDs supports research and research training aimed at preventing and ameliorating common and rare neuromuscular and neurodevelopmental disorders, such as Down syndrome, Fragile X syndrome, and Rett syndrome; inborn errors of metabolism; autism spectrum disorders; conditions currently or potentially detectable through newborn screening; and IDDs that have no identified cause that are not associated with a specific syndrome. The Eunice Kennedy Shriver Intellectual and Developmental Disabilities Research Centers employ research technologies such as bioinformatics, biostatistics, genomics, proteomics, metabolomics, imaging, and behavioral testing to support a broad range of projects. The Centers for Collaborative Research in Fragile X, also known as the Fragile X Syndrome Research Centers, support research to improve the diagnosis and treatment of Fragile X syndrome (FXS) by stimulating multidisciplinary and multi-institutional research from the bench to the community. FXS is the most common inherited form of intellectual disability, occurring in about 1 in 4,000 males and 1 in 8,000 females. One Fragile X Center conducted a clinical trial of ganaxolone, a compound that has been used to reduce anxiety in animal models and to treat epilepsy and traumatic stress disorders in both adults and children. The researchers found that children with FXS who had a higher baseline anxiety or lower cognitive abilities showed improvements in attention, hyperactivity, and anxiety while taking ganaxolone, with no serious adverse effects. Autism spectrum disorder (ASD) is one of the more common IDDs, affecting as many as 1 in 68 children. NICHD supports a broad portfolio of research on ASD, encompassing research on genetic and other causes, especially including the interaction between genes and environmental exposures; comorbid conditions, including gastrointestinal dysfunction and mental illness; early screening and diagnosis; and developing effective interventions. An important component of NICHD's portfolio is the NIH Autism Centers of Excellence (ACE) Program, supported by NICHD along with National Institute on Deafness and Other Communication Disorders (NIDCD), NIEHS, National Institute of Mental Health (NIMH), and National Institute of Neurological Disorders and Stroke (NINDS). The ACE program is designed to build on discoveries from the last 10 years by supporting innovative, multi-disciplinary research that promises to yield interventions and services for people with ASD. For instance, siblings of children diagnosed with autism spectrum disorder have a higher risk of developing the disorder compared to those in the general population. Using MRI and a field of computer science called machine learning, ACE researchers have found that structural differences in the brains of 6 or 12-month old infants may help predict the development of autism spectrum disorder by two years of age among infants with a high familial risk. The IDD program emphasizes bringing resources, patients, and researchers together. DS-Connect® is a research registry where people with Down syndrome (DS) and their families can connect with researchers and healthcare providers; express interest in participating in clinical studies on DS, including studies of new medications and other treatments; and take confidential health-related surveys aimed at understanding the health of people with DS across their lifespans. In searching for causes underlying IDDs, biomedical research has uncovered several diseases that could be related to a decrease in myelin in the brain. Vital to brain function, myelin is a substance that allows regions of the brain to communicate with each other. Angelman syndrome results in delays in development, speech impairment, problems with balance, and microcephaly, a condition in which a child’s head is much smaller than expected. Analyzing brain structure with MRI in a mouse model of Angelman syndrome, researchers found that the overall volume of white matter was decreased, which can lead to microcephaly. A mouse model of tuberous sclerosis complex (TSC), which affects 1 in 6,000 newborns worldwide, showed that deleting the genes affecting TSC stops the development of oligodendrocytes, the cells that produce myelin in the brain. Comparing the postmortem brains of individuals who did or did not have DS, researchers found differences in over 1,400 genes; many genes that were less expressed in individuals with DS were involved in the development of oligodendrocytes and production of myelin. Demography and Behavior The program in demography and behavior includes NICHD's portfolio on behavioral and social influences on health. Results from an NICHD-supported study of youth aging out of foster care suggest that foster children's experiences vary significantly in the type and number of adverse events that happen to them early in life, and these variations could help predict different pathways for subsequent health, psychosocial, and other outcomes. Researchers found that youth who had large numbers of adverse events related to their parents or caregivers – such as physical or sexual abuse, neglect, or mental illness of a caregiver – had significantly higher rates of mental health treatment than children without these specific experiences. In contrast, children who had large numbers of adverse events related to emotional trauma from events in their environment – such as witnessing violence or experiencing a fire or natural disaster – were more likely to report drug and alcohol abuse symptoms and criminal behavior. Both types of adverse events in childhood were associated with poorer outcomes in adulthood, but the trajectories differed depending on the types of events experienced in childhood. Health disparities research cuts across all NICHD's programs, and is a key component of many of the Institute's demographic and behavioral studies. A recent NICHD-supported study documented disparities in race and family income in the use of early intervention services among toddlers with developmental delays. The NICHD’s Learning Disabilities Research Centers support research to identify genetic and neurobiological characteristics of children, adolescents, and adults with learning disabilities; develop and validate classification systems for learning disabilities; expand knowledge about ways to improve comprehension for individuals who struggle with reading; assess the impact of attention-deficit/hyperactivity disorder (ADHD) on reading; and investigate the relationship between executive function skills and learning. Complementing the Centers, the NICHD’s Learning Disabilities Innovation Hubs focus on understudied research topics that address the causes, symptoms, and treatments of learning disabilities that impact reading, writing, and mathematical reasoning. Recently, NICHD-supported researchers compared the effects of ADHD treatment alone, intensive reading intervention alone, and a combined treatment for children with both ADHD and reading disability (RD). The results indicated that children with co-occurring ADHD and RD require disorder-specific treatments, and that combining treatments does not enhance their effectiveness. Rehabilitation Through the National Center for Medical Rehabilitation Research (NCMRR), NICHD fosters research and research training to enhance the health, productivity, independence, and quality of life of people with disabilities at all ages. This program supports a broad range of research, including efforts to understand the underlying biology of injury and disability, and the body’s mechanisms of recovery and adaptation. Rehabilitation research investments are guided by the comprehensive five-year NIH Research Plan on Rehabilitation, developed in 2016. The plan was developed under the leadership of NCMRR in collaboration with stakeholders across NIH and other Federal agencies, as well as researchers and representatives of individuals with disabilities and practitioners. The plan identifies six priority areas: • Rehabilitation across the lifespan, to ensure that interventions are designed and tested appropriately – for example, including play-based rehabilitation approaches for young children and adaptive physical exercise programs for seniors; • Family and community, to promote rehabilitation from hospital to home, with the full involvement of caregivers; • Technology use and development, to take advantage of state of the art technology in fields including computational science, robotics, and prosthetics; • Research design and methodology, to improve research approaches and study designs to help researchers generate consistent clinical data from individuals with a variety of underlying conditions; • Translational science, to capitalize on advances in fundamental science and take advantage of better understanding of genomic and other cell-based, process-level contributors to plasticity and healing; • Building research capacity and infrastructure, to develop the next generation of rehabilitation scientists and support interdisciplinary collaborations. NCMRR places a special emphasis on translational research to apply gains in fundamental science to creating real-world interventions that can help people with disabilities where they live and work. Two new technologies that assist in rehabilitation from disabilities, injuries or stroke now have Class II medical device clearance from the FDA. The first, an upper arm prosthetic interface, uses pattern-recognition technology to strengthen and improve the analysis of electric signals in remaining muscles after amputation; this gives an amputee greater control and movement of the prosthetic limb. The second, a Virtual Occupational Therapy Assistant software system, helps stroke survivors and others with neurological impairments with daily living tasks, such as cooking, cleaning or shopping, thus helping to reacquaint these patients with once-routine activities. NCMRR takes a collaborative approach to rehabilitation science, working with other NIH ICs, Federal agencies, the business community, advocates, and other stakeholders. Recently, researchers supported by NCMRR and Centers of Disease Control and Prevention (CDC) used a large national database funded in part by other HHS agencies to assess whether children seeking mental health care after a mild Traumatic Brain Injury (mTBI) had previous mental health diagnoses, or whether the onset of the disorders was new. The scientists found that 27 percent of the total number of children in the study had a mental health diagnosis before their injury, and that an mTBI injury was associated with increased use of mental health services in all of the children, whether or not they had a previous diagnosis.
Fiscal Year 2020 Reproductive Health, Pregnancy, and Perinatology: The program in reproductive health, pregnancy, and perinatology supports basic, clinical, and translational research on gynecologic disorders, contraception, fertility and infertility, pregnancy, and newborn care. NICHD manages a broad research portfolio to understand, treat, and prevent common, painful, and costly reproductive health conditions, including uterine fibroids, chronic pelvic pain, pelvic floor disorders, and endometriosis. NICHD supports research on developing potential interventions, as well as comparing the effectiveness of current options. For example, one randomized controlled clinical trial found that gabapentin, an approved treatment for types of nerve pain, was not effective in treating vulvodynia. Another recent study found that two common surgeries to treat pelvic organ prolapse had similar success rates. To strengthen the scientific research base in reproductive health, NICHD plans to stimulate additional research into the role of pluripotent progenitor/stem cells in the pathogenesis and potential treatment of common gynecologic disorders. NICHD also has encouraged small businesses to collaborate with scientists and clinicians to develop, advance, and validate new devices and methods for non-invasive diagnosis of endometriosis, adenomyosis, and/or uterine fibroids, which affect millions of women in the United States. Millions of couples across the United States have difficulty conceiving and establishing a healthy pregnancy, yet only limited information is available to understand the causes of infertility, minimize risk factors, and improve treatment options. To remedy this gap, NICHD supports basic, translational, clinical, and population research, such as assessing how dietary, lifestyle, and other risk factors affect fertility in both men and women. Two separate teams of scientists recently uncovered evidence that women with iodine deficiency, and women with insufficient vitamin D levels, are less likely to become pregnant. Other risk factors for infertility focus on the male partner. One NICHD-funded study indicated that among couples being treated for infertility, depression in the male partner was linked to lower pregnancy chances, while depression in the female partner did not influence the rate of live birth. NICHD-supported pregnancy-related research spans preconception care, pregnancy, fetal growth, labor and delivery, and maternal and neonatal health. Beyond initiating the ACT NOW study mentioned earlier, NICHD has also supported studies on the medications used to treat opioid use disorder in pregnant women. Compared to women treated with methadone, women treated with buprenorphine had more prenatal care visits, a higher chance of delivering vaginally, and a lower risk of testing positive for illicit drugs after treatment began. These results underscore the complexity of selecting the most appropriate medication given a patient's disease severity, mental health, and recovery resources. NICHD supports prevention research to help reduce the dangers associated with high-risk pregnancies and preterm birth, as well as the associated lifelong problems for mother and child. In analyzing data on more than 21,000 pregnancies, NICHD-supported scientists found significant associations between taking vitamin D supplements before pregnancy and a lower risk of gestational diabetes. In a study performed in New York City, researchers found that maternal exposure to specific types of air pollution particles four to six days before giving birth were associated with increased risk of acute-onset placental abruption. NICHD’s ongoing Human Placenta Project, designed to provide information about placental health noninvasively and in real time, is yielding new insights to help researchers further their efforts to improve maternal health and pregnancy outcomes. Child Health: Research on child health builds on the basic science of biological processes that govern healthy or atypical development. Child health research encompasses translational research, health promotion and prevention of disease, behavioral and social science research, and clinical studies in pediatric pharmacology, trauma and critical illness, endocrinology and metabolism, infectious diseases, and other aspects of pediatric and adolescent medicine. NICHD’s basic research portfolio on developmental biology has led to understanding normal embryonic development, as well as mechanisms that cause structural and functional birth defects. Researchers continue to use and expand the transformational genomic sequencing data developed under the NIH Common Fund’s Gabriella Miller Kids First Pediatric Research Program, which has a major focus on structural birth defects. The program’s ten-year effort will yield a powerful, integrated publicly-available pediatric data resource, populated by genomic and phenotypic data. Already, data sets from children with some cancers, congenital heart disease, and congenital diaphragmatic hernia are available to researchers worldwide. The resource will enable researchers to perform data mining across diverse disorders, to understand shared developmental pathways. Other transformational NIH tools include The Bloomington Drosophila Stock Center and the Zebrafish International Resource Center, two comprehensive resources that develop animal models for experiments that enable studies on the developmental origins and mechanisms of human diseases in infancy and childhood, as well as health across the lifespan. Powerful new techniques allow efficient production of mutations that shed light on genes that affect early development, organ growth, physiology, and behavior. Infants and older children differ physiologically from adults, with different considerations at different developmental stages. BPCA recognizes that therapies developed for and tested in adults typically require specialized research to ensure safe and effective pediatric use. Approved BPCA clinical trials are managed by the Pediatric Trials Network (PTN), an alliance of clinical research sites that cooperate to assess safety and effectiveness of pharmaceuticals in children. Accounting for possible variations in how a drug affects children at different developmental stages, researchers have produced data on appropriate intravenous and oral dosing. For example, a recent clinical study focused on drug therapy (pantoprazole) for gastroesophageal reflux in children and adolescents with obesity, who are more likely than their peers to have this difficult condition. Study findings indicated that lower, rather than higher doses, are appropriate for children with obesity; their bodies eliminated the drug more slowly, and their exposure to the drug was higher. Another research team examined the common practice of using diuretic medicine to help drain fluid from the lungs of preterm infants, and found, unexpectedly, that extremely preterm infants who received diuretics were more likely to require additional respiratory support in the days after the drug therapy, compared to others with similar respiratory problems who were not treated by the drugs. Data from intensive care units also indicated that hospitals varied widely in their use of the diuretic therapy, raising questions about a clinical practice with little previous research evidence to support its application. The rapid rise of opioid use in the U.S. over the last decade has raised concerns about prescription opioids for young children and adolescents. Researchers examined records of children enrolled in the Tennessee Medicaid program between 1999 and 2004, finding that opioids were prescribed in about 15 percent of the children studied, most commonly for short-term or less severe conditions, such as dental procedures, outpatient medical procedures, or surgery. In well over a million prescriptions, one of every 2,611 was followed by an adverse event, such as an emergency department visit, hospitalization, or death. Of the adverse events, 70 percent were related to the prescribed opioid. For children affected by trauma or critical illness, evidence-based emergency and critical care can be lifesaving. NICHD’s Collaborative Pediatric Critical Care Research Network (CPCCRN) aims to improve care for infants, children, and adolescents with life-threatening, often complex conditions that may require technology-intensive interventions. For example, extracorporeal membrane oxygenation (ECMO) helps patients with impaired cardiac and lung function by infusing the blood with oxygen and eliminating carbon dioxide in a machine, then channeling the blood back into the body. Researchers found that if the availability of oxygen is too low or too high, patients may have worse outcomes; these findings will help optimize ECMO therapy. In another study, to determine optimum cardiac pulmonary resuscitation (CPR) for children experiencing cardiac arrest, CPCCRN researchers analyzed hospital monitors and charts of 164 children during CPR at 11 U.S. hospitals over a period of three years. They found that maintaining age-specific blood pressure rates during CPR for infants and for children age one year or older gave these children a 70 percent greater likelihood of surviving cardiac arrest and a 60 percent higher likelihood of survival with favorable neurological outcomes. These data provide a foundation to improve CPR guidelines for infants and children. A portion of the child health program supports and conducts domestic and international research related to infectious diseases in children and adolescents. NICHD-supported researchers developed a way to make a four- to eight-month treatment for multidrug-resistant tuberculosis effective and less painful for children and adolescents by administering the amikacin antibiotic injections with lidocaine, a local anesthetic. Intellectual and Developmental Disabilities: Intellectual and developmental disabilities (IDDs) were once thought to be permanent and untreatable, but new basic science discoveries have challenged this belief, inspiring renewed efforts to improve the lives of individuals with IDDs. The program on IDDs supports research and research training aimed at preventing and ameliorating common and rare neurodevelopmental and neuromuscular disorders, such as Down syndrome, Fragile X syndrome (FXS), and Rett syndrome; inborn errors of metabolism; autism spectrum disorders; congenital conditions currently or potentially detectable through newborn screening; and IDDs that have no identified cause or are not associated with a specific syndrome. The Eunice Kennedy Shriver Intellectual and Developmental Disabilities Research Centers (IDDRCs) employ advanced technologies to support a broad range of research projects. For example, one IDDRC project studies Angelman syndrome, a neurodevelopmental disorder that causes global developmental delay, intellectual disability, epilepsy, and other symptoms. Angelman syndrome occurs in 1 in 12,000 to 20,000 people. The IDDRC researchers assessed the effects of levodopa, a drug used to treat Parkinson’s disease that has been used off-label to treat Angelman syndrome. They found that levodopa was not effective for children with Angelman syndrome when compared to a placebo. Similarly, the Centers for Collaborative Research in Fragile X support research to improve the diagnosis and treatment of FXS by stimulating multidisciplinary and multi-institutional research. In 2018, a brain imaging study of infants with FXS showed that 12 of 19 major white matter connections were significantly diminished in children with FXS, compared with typically developing children. NICHD is leading the effort to update the NIH’s national research plan on Fragile X syndrome and associated disorders. Up to half of people with Fragile X also meet the criteria for autism spectrum disorder (ASD). NICHD supports a broad portfolio of research on ASD, encompassing research on genetic and other causes, especially including the interaction between genes and environmental exposures; comorbid conditions, including gastrointestinal dysfunction and mental illness; early screening and diagnosis; and developing effective interventions. Another important component of NICHD's portfolio is the NIH Autism Centers of Excellence (ACE) Program, supported by NICHD along with four other NIH Institutes. The ACE program supports innovative, multi-disciplinary research that promises to yield interventions for people with ASD. As more individuals with IDDs are included in clinical research, more data have become available about comorbid conditions. For example, researchers found that compared with typically-developing children, children with ASD and gastrointestinal symptoms have an imbalance in their immune system responses, which could be influenced by or could influence genetic changes that would impair normal gut function. Newborn screening programs across the United States currently screen four million infants each year for conditions that, if left untreated, may predispose to IDDs. NICHD’s Newborn Screening Translational Research Network (NBSTRN) works with other organizations to provide infrastructure support to researchers working on projects relevant to newborn screening. Another NICHD-sponsored initiative encourages studies that will lead to a broad understanding of the natural history of disorders that could benefit from early identification via newborn screening, to facilitate appropriate interventions for infants. Demography and Behavior: The program in demography and behavior incorporates NICHD's strong portfolio on behavioral and social influences on health. The program also supports research and research training in the characteristics and dynamics of populations and subpopulations. Researchers studied a home visiting program called Minding the Baby (MTB) that focused on first-time mothers and their babies, consisting of weekly home visits from a social worker and pediatric nurse beginning in early pregnancy and continuing until the child is two years old. The MTB program was not designed as an obesity prevention program but focused more broadly on mother-child attachment and health. However, the study results clearly showed that the rate of child obesity at age two was significantly lower in the MTB group. NICHD continues to support the Population Dynamics Centers Research Infrastructure Program, providing resources for analyses of health and development at the population level. NICHD research on learning disabilities and associated symptoms seeks to understand causes and risk factors for these complex conditions. One of the most common neurobehavioral disorders in children is attention deficit hyperactivity disorder (ADHD). While not in itself a learning disability, ADHD is associated with challenges in focus, attention, and behavior control, and thus can interfere with a child’s learning. Using high-resolution brain-scans, researchers have found significant differences in brain structures between children as young as age four with and without ADHD symptoms. The researchers will continue to monitor brain changes and differences as these children grow. In another project, researchers found that about 9 percent of a largely urban, low-income, minority population of children had elevated blood lead levels that were associated with an increased risk of ADHD in boys, though not in girls. For the boys, the risk of ADHD was less if their mothers had had low levels of stress and/or high blood levels of high-density lipoprotein (which combats high blood cholesterol) during pregnancy. Health disparities research cuts across all NICHD's programs and is an essential component of many of the Institute's demographic and behavioral studies. For example, researchers assessed whether a child’s race or ethnicity – or the race or ethnicity of the prescriber -- was associated with differences in prescribing opioid or non-opioid medication. White children in outpatient health care were more commonly prescribed opioids than minority children, except that opioid prescribing for Native American children was similar to that of white children. Black children who had a black health care provider were less likely to receive an opioid prescription compared with black children who had a white health care provider. Rehabilitation: The NICHD’s National Center for Medical Rehabilitation Research (NCMRR) fosters research and research training to enhance the health, independence, and quality of life of people with disabilities. With a dedicated budget, and a leading role in trans-NIH and broader medical rehabilitation research collaborations, this program supports and contributes to advancing a broad range of research, including efforts to understand the underlying biology of injury and disability, and the body’s mechanisms of recovery and adaptation. NCMRR’s rehabilitation research investments continue to be guided by the 2016 comprehensive NIH Research Plan on Rehabilitation , developed with stakeholders across the NIH and other Federal agencies, as well as researchers and representatives of individuals with disabilities and practitioners. The plan identifies the following six priority areas: rehabilitation across the lifespan; family and community; technology use and development; research design and methodology; translational science; and building research capacity and infrastructure. NCMRR will lead a multi-Institute initiative to stimulate pediatric rehabilitation research. Examples of priority areas include children with spinal cord injury, spina bifida, cerebral palsy/stroke, and limb loss. This initiative complements existing NCMRR investments, including a large, international study to evaluate the impacts of interventions on outcomes in children with severe traumatic brain injury (TBI), and large trials of “constraint-induced movement therapy” (CIMT) for children with cerebral palsy (CP). In CIMT, a device forces patients to use an impaired limb by restricting the patient’s ability to use their unaffected limb. NCMRR places a special emphasis on translational research to create and refine real-world interventions that can help individuals with disabilities where they live and work. For example, researchers have typically developed and tested assistive devices for stroke survivors in controlled clinical research settings, where the participants practice simulated functional tasks. Recently, NCMRR-supported research tested a new spring-operated wearable device to help stroke survivors perform real-life activities at home. NCMRR takes a collaborative approach to rehabilitation science, working with other NIH Institutes, Federal agencies, the business community, advocates, and other stakeholders. NCMRR interactions with the Centers for Medicare and Medicaid Services (CMS) Coverage and Analysis Group made clear that the evidence base of clinical care for amputees is poorly developed. Further, some technologies that may seem to address challenges of individuals living with limb loss do not necessarily translate into functional improvements. A new collaboration between NCMRR and the Department of Defense (DOD) will, within five years, create a national limb-loss and preservation registry—combining clinical and other information on active duty military personnel, veterans, and civilian members of the population who have experienced limb loss.