# Data Coordinating Center for the NICHD Neonatal Research Network (U24)

> **NIH NIH U24** · RESEARCH TRIANGLE INSTITUTE · 2020 · $7,000,000

## Abstract

Project Summary
Critical and persistent gaps in the evidence base for neonatal medicine require innovative and rigorous
multicenter studies to address them. The NICHD Neonatal Research Network (NRN) investigates the safety
and efficacy of treatment and management strategies for newborn infants. There is a crucial need for an
independent Data Coordinating Center (DCC) that can provide high-quality and impartial biostatistical expertise
to help the NRN target its resources and optimize its scientific impact by (a) helping the NRN identify research
topics of high priority, (b) providing objective statistical expertise for the design and analyses of rigorous and
feasible studies (especially masked randomized trials and interim monitoring thereof), (c) developing efficient
processes and systems for effective use of limited resources, (d) ensuring standardization of study design,
development, data collection, and analyses, and (e) dissemination of study results. RTI has been the DCC for
the NRN since 1998 and proposes to continue in this role for the next 5 years. We will maximize NRN scientific
productivity by (1) enhancing the scientific rigor of the Network with innovative trial designs and statistical
methods that address the unique challenges in neonatal research; (2) optimizing productivity by providing
flexible and efficient data and study management, and promoting data sharing, integration and harmonization;
(3) protecting participant safety and study integrity through reports to the Data Safety and Monitoring
Committee; (4) providing timely data analysis, collaborating with investigators on all NRN studies and
publications; (5) leveraging the NRN infrastructure and data for external partnerships that support and amplify
Network scientific goals; and (6) providing the logistical, communications, and regulatory support necessary to
run an efficient and productive multicenter clinical research network. Dr. Abhik Das, the proposed DCC PI, has
extensive experience in neonatal clinical studies, leading the NRN DCC for the past 12 years. He will be
assisted by Alternate PIs Drs. Marie Gantz and Carla Bann and staff with significant NRN experience. Informed
by our past accomplishments, we will support continued success of the NRN in advancing evidence-based
neonatal care. This application has unique strengths to help advance the NRN research agenda: (1) a highly
qualified and motivated PI and staff with in-depth knowledge and experience in neonatal research (including
existing NRN data and active/planned studies), enabling seamless continuation of NRN research without
additional training or resources; (2) proven scientific productivity, documented by the quality and quantity of
NRN studies and publications supported by RTI that have changed clinical practice; (3) a state-of-the-art
infrastructure of tools, processes, and systems that are flexible and customized to the needs of the NRN; (4)
multidisciplinary experts who can collaborate with NRN Investi...

## Key facts

- **NIH application ID:** 10170501
- **Project number:** 3U24HD095254-03S1
- **Recipient organization:** RESEARCH TRIANGLE INSTITUTE
- **Principal Investigator:** Abhik Das
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $7,000,000
- **Award type:** 3
- **Project period:** 2018-04-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10170501

## Citation

> US National Institutes of Health, RePORTER application 10170501, Data Coordinating Center for the NICHD Neonatal Research Network (U24) (3U24HD095254-03S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10170501. Licensed CC0.

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