Key Dates

Related Announcements

• July 12, 2023 - PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed). See NOFO PA-23-232.
• July 12, 2023 - PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required). See NOFO PA-23-233.
• July 12, 2023 - PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed). See NOFO PA-23-230.
• July 12, 2023 - PHS 2022-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required). See NOFO PA-23-231.
• June 06, 2023 - ClinGen Genomic Curation Expert Panels (U24 Clinical Trial Not Allowed). See NOFO PAR-23-199.
• June 02, 2023 - Native American Research Centers for Health (NARCH) (S06 Clinical Trial Optional). See NOFO PAR-23-166.
• March 2, 2023 - Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R21 Clinical Trial Optional). See NOFO PAR-23-131.
• March 2, 2023 - Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional). See NOFO PAR-23-130.
• November 28, 2022 - Multisite Clinical Research: Leveraging Network Infrastructure to Advance Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (U01 Clinical Trial Optional). See NOFO PAR-23-037.
• August 24, 2022 - NICHD Research Education Programs (R25 Clinical Trial Not Allowed). See NOFO PAR-22-224.
• January 10, 2022 - Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Required). See NOFO PAR-21-357.
• January 10, 2022 - Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Not Allowed). See NOFO PAR-22-060.
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• May 19, 2021 - Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 Clinical Trial Not Allowed). See NOFO PAR-21-155.
• May 19, 2021 - Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 Clinical Trial Required). See NOFO PAR-21-154.
• April 21, 2021 - NICHD Small Research Grant Program (R03 Clinical Trial Required). See NOFO PA-21-221 .
• April 21, 2021 - NICHD Small Research Grant Program (R03 Basic Experimental Studies with Humans Required). See NOFO PA-21-231 .
• October 28, 2020 - Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (Parent F31-Diversity). See NOFO PA-21-052.
• October 21, 2020 - Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31). See NOFO PA-21-051.
• October 26, 2020 - Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32). See NOFO PA-21-048.
• October 26, 2020 - Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions with NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30). See NOFO PA-21-049.
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• May 12, 2020 - Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required). See NOFO PA-20-202.
• May 12, 2020 - Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Not Allowed). See NOFO PA-20-203.
• May 12, 2020 - Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Basic Experimental Studies with Humans Required). See NOFO PA-20-204.
• May 12, 2020 - Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Not Allowed). See NOFO PA-20-205.
• May 12, 2020 - Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Required). See NOFO PA-20-206.
• May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required). See NOFO PA-20-194.
• May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed). See NOFO PA-20-195.
• May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required). See NOFO PA-20-196.
• May 7, 2020 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed). See NOFO PA-20-200.
• May 5, 2020 - Research Project Grant (Parent R01 Clinical Trial Required). See NOFO PA-20-183.
• May 5, 2020 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required). See NOFO PA-20-184.
• May 5, 2020 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See NOFO PA-20-185.

Issued by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

This Notice of Special Interest (NOSI) aims to support transdisciplinary research to elucidate the genotypic, phenotypic, and environmental underpinnings of stillbirth and to identify potential targets for intervention and prevention.

Research supported by this NOSI is expected to:

1. Contribute to the discovery of new risk factors and interactions with stillbirth.
2. Explore the development of real-time placental evaluation imaging techniques that may lead to identification of standardized pathologic patterns predictive of risk for stillbirth.   
3. Expand knowledge of the mechanisms by which specific genetic and environmental risk factors and their interactions lead to stillbirth.
4. Identify the factors contributing to racial, ethnic, and nativity disparities in stillbirth. 
5. Develop the most appropriate strategies for stillbirth prevention, with an emphasis on high-risk communities.  
6. Establish baseline normative data on pregnancy physiology that will aid in implementing best practice(s) in care in subsequent pregnancies after stillbirth.
7. Develop approaches for identifying and stratifying pregnant people at increased risk of stillbirth.
8. Improve clinician and healthcare provider tools for stillbirth risk assessment. 
9. Develop targeted clinical interventions for the prevention of stillbirth using indicators such as placental development, function, and biomarkers, fetal movement, and fetal growth.
10. Develop and implement approaches to enable best decision practices for timing of delivery for pregnant people with risk factors for stillbirth.
11. Assess quality of care and link specific care interventions to data on outcomes to learn about the psychological burden on the pregnant person, their family, and healthcare providers. 

Background

Stillbirths account for a large proportion of perinatal mortality. According to vital statistics, stillbirth affects one in 160 pregnancies, with 24,000 babies stillborn each year. More than 60% of stillbirth cases remain unexplained, with no known cause after the exclusion of common causes, such as obstetric complications, infections, placental insufficiency or abruption, umbilical cord complications, and congenital abnormalities with or without known genetic cause. People who have experienced stillbirth are almost five times as likely to experience another stillbirth or other pregnancy associated complication. Moreover, nearly 1 in 4 stillbirths could be preventable, and the rate of stillbirth is considerably higher among Black, American Indian, and Alaska Native people. 

NICHD formed the Stillbirth Working Group of Council, a subgroup of NICHD’s National Advisory Child Health and Human Development Council, in response to a U.S. Department of Health and Human Services request to lead a Congressionally mandated task force to examine stillbirth in the U.S., with a focus on the following issues:

• Current barriers to collecting data on stillbirths in the United States
• Communities at higher risk for stillbirth
• Psychological impact and treatment for pregnant people and parents following stillbirth
• Known risk factors for stillbirth 

Research Objectives

This NOSI is part of a multi-pronged approach in response to the Stillbirth Working Group’s recommendations. A wide variety of risk factors—including pregnancy complications, chronic health conditions, genetics, environmental factors, and social determinants of health—have been associated with stillbirth and other adverse pregnancy outcomes. However, known risk factors account for a limited proportion of the variation in stillbirth rates. More research is needed to discover additional risk factors and delineate the mechanisms of how these risk factors and their interaction lead to stillbirth.

Topics of interest for this NOSI include but are not limited to:

• Characterize risks for stillbirth, with an emphasis on parental contribution (other than genetic) from conception, fetal development, and their contributions to stillbirth 
• Investigate the genetic contribution of parental, conceptus and fetal polymorphisms and de novo mutations in stillbirth. 
• Investigate gene function involved in stillbirth to provide the causal link between possible genetic variants and patient phenotypes. 
• Methodological research on improving accuracy of stillbirth data collection along with the accuracy of other data needed to identify disparities in stillbirth.
• Identify potentially modifiable environmental influences and their role in stillbirth.
• Identify social, behavioral, and structural factors that impact the likelihood of experiencing stillbirth. 
• Interventions to address the impact of structural causes of stillbirth. 
• Elucidate the racial, ethnic, and nativity disparities impacting stillbirth. 
• Develop research capacity that serves specific contexts and communities with emphasis on highest burden settings. 
• Conduct clinical trials that will lead to stillbirth risk reduction through known interventions.
• Conduct translational and implementation research to lead to a better understanding of effective interventions. 
• Determine causes of and differential susceptibility to infection, and maternal-fetal immune responses associated with stillbirth, utilizing high dimensional systembiology approaches.
• Develop novel techniques, interventions, methodologies, and computational models that could aid in stratifying and targeting high-risk populations to substantially advance research and stillbirth prevention. 
• Investigate tools to assess the support needed by birthing people and families after stillbirth due to pregnancy or childbirth complications. 
• Investigate best practices in supporting health-care workers caring for people experiencing stillbirth.
• Develop non-invasive or minimally invasive autopsy techniques for detecting cause of death to increase autopsy uptake rates and contribute to the identification of cause of death to aid in the development of stillbirth prevention strategies.
• Develop predictive models to assess the likelihood of stillbirth integrating genetic, environmental, and medical status and history. 

The following types of projects are not considered priorities under this NOSI:

• Research that is exclusively an efficacy study.
• Comparative research on stillbirths in the United States versus other countries is within the scope of this initiative. Research that does not include a major U.S. component is not within scope.
• Research only involving populations outside the United States
• Research on neonatal and infant mortality trends and disparities in relation to stillbirths are allowable, but the focus of the research must be stillbirths in the United States.

Application and Submission Information

This notice applies to due dates on or after October 5, 2023, and subsequent receipt dates through November 17, 2026. No applications will be accepted on or after November 17, 2026.  

Submit applications for this initiative using one of the following notices of funding opportunity (NOFO) or any reissues of this announcement through the expiration date of this notice.

• PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-184 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PAR-23-037 - Multisite Clinical Research: Leveraging Network Infrastructure to Advance Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (U01 Clinical Trial Optional)
• PAR-23-199 - ClinGen Genomic Curation Expert Panels (U24 Clinical Trial Not Allowed)
• PAR-23-166 - Native American Research Centers for Health (NARCH) (S06 Clinical Trial Optional)
• PAR-23-131 - Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R21 Clinical Trial Optional)
• PAR-23-130 - Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional)
• PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
• PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
• PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
• PA-21-221 - NICHD Small Research Grant Program (R03 Clinical Trial Required)
• PA-21-231 - NICHD Small Research Grant Program (R03 Basic Experimental Studies with Humans Required)
• PAR-21-155 - Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 Clinical Trial Not Allowed)
• PAR-21-154 - Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 Clinical Trial Required)
• PAR-21-357 - Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Required)
• PAR-22-060 - Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Not Allowed)
• PA-23-232 - PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-23-233 - PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
• PA-23-230 - PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• PA-23-231 - PHS 2022-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
• PAR-22-224 - NICHD Research Education Programs (R25 Clinical Trial Not Allowed)
• PA-20-202 - Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required)
• PA-20-203 - Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Not Allowed)
• PA-20-204 - Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Basic Experimental Studies with Humans Required)
• PA-20-205 - Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Not Allowed)
• PA-20-206 - Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Required)
• PA-21-052 - Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (Parent F31-Diversity)
• PA-21-051 - Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31)
• PA-21-048 - Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32)
• PA-21-049 - Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions with NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30)

All instructions in the SF424 (R&R) Application Guide and the notice of funding opportunity used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-HD-23-021 in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed notice of funding opportunity.

Scientific/Research Contact(s)

Monica Longo, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 240-204-4605
Email: [email protected]