NICHD – NICHD Neonatal Research Network (NRN): Clinical Centers (UG1 Clinical Trial Optional)

May 6, 2022 by dld5dt@virginia.edu

Purpose:

The purpose of the Neonatal Research Network (NRN) is to improve healthcare and outcomes for newborns. This includes finding ways to improve the chances for survival without neurodevelopmental impairment for infants born premature, low-birth weight, or with other serious conditions. NICHD expects the NRN to be its primary and first-line infrastructure involved in implementing multi-site neonatal clinical trials.

Background:

As such, the NRN helps address several Congressional and public health goals:

  • The Prematurity Research Expansion and Education for Mothers Who Deliver Infants Early (PREEMIE) Act (Public Law 109-450) was passed originally in 2006 and reauthorized in 2018 (Public Law 115-328) to: (1) reduce rates of preterm labor and delivery, (2) work toward an evidence-based standard of care for pregnant peopleat risk of preterm labor or other serious complications, and for infants born preterm, and (3) reduce infant mortality and disabilities caused by premature birth.
  • The Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), established under the 21st Century Cures Act (Public Law No: 114-255), recommended that the Secretary of Health and Human Services “increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women.”
  • Ongoing and potential future public health crises that impact the health of pregnant people and/or their infants, such as the COVID epidemic, Zika epidemic, and the opioid crisis.

The NRN will also help NICHD address its Strategic Plan 2020, specifically for: Theme 4, Improving Child and Adolescent Health; and Theme 5, Advancing Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities.

The objective of the NRN, therefore, is to conduct definitive, rigorous, and reproducible, multi-site clinical trials and observational studies in newborns and lactating people, providing evidence to guide neonatology, pediatric pharmacology, and lactation clinical practice. This Network of research institutions will work collaboratively to implement common protocols to enroll and follow-up enough patients to achieve statistical power to answer protocol hypotheses more rapidly and definitively than individual centers acting alone.

Study designs may include, but are not limited to: investigational new drug or device, comparative effectiveness, and management trials; biomarker validation studies that are immediately preparatory to trials; and observational studies. Studies may assess both short-term (clinical) and long-term infant and child outcomes (i.e., up to school age). The Network may conduct Phase 3 pharmacologic research to address gaps in knowledge for the use of drugs and therapeutics during pregnancy and lactation – both therapeutics designed to treat lactation complications and therapeutics for other health issues that people may need to use while lactating. Phase 1 and 2 trials will generally be conducted outside of this Network but may be considered on a case-by-case basis (e.g., for trials in rare conditions). When relevant and appropriate, NICHD encourages the inclusion of genomic and proteomic studies, sub-studies, and/or collection of related biospecimens for such research. Examples of studies conducted in the Network can be found at: https://neonatal.rti.org/index.cfm?fuseaction=home.studies.

The Network will also be uniquely poised to collaborate on studies and projects with other networks and initiatives – such as the NICHD Maternal-Fetal Medicine Units (MFMU) Network, the NICHD Maternal and Pediatric Precision in Therapeutics (MPRINT) Initiative, the NIH Helping to End Addiction Long-term (HEAL) Initiative, the NIH Researching COVID to Enhance Recovery (RECOVER) Initiative, the Foundation for the NIH, and other NIH institutes and Federal agencies, such as the Centers for Disease Control and Prevention.

Key Dates:

Open Date (Earliest Submission Date): July 12, 2022
Letter of Intent Due Date(s): 30 days prior to the application due date
Applications Due: August 12, 2022

URLs for more information:

https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-23-002.html

http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-23-001.html

Filed Under: Funding Opportunities