# Component A: BD-STEPS II Core at North Carolina Center for Birth Defects Research and Prevention (NC BDSTEPS II Core)

> **NIH ALLCDC U01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $900,000

## Abstract

Project Abstract
Birth defects are a leading cause of infant mortality, morbidity and healthcare costs, yet the etiology of most
birth defects remains unknown. Established in 2002, the North Carolina Center for Birth Defects Research
and Prevention (NCCBDRP) has been a major contributor to the National Birth Defects Prevention Study
(NBDPS) and Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS I). The NCCBDRP is a
collaboration between the Department of Epidemiology at the Universityof North Carolina (UNC) Gillings
School of Global Public Health in Chapel Hill, and the North Carolina Birth Defects Monitoring Program
(NCBDMP) at the North Carolina Division of Public Health in Raleigh. BD-STEPS II will build upon NBDPS'
and BD-STEPS I's population-based, multi-center case-control study design to identify causes of birth defects
using epidemiologic and genetic research methods, and provide information with strong potential for translation
to public health prevention efforts. The NCCBDRP's Specific Aims are to (1) Implement the standardized BD-
STEPS II protocol in our well-defined, demographically diverse study region, including: (a) Utilize our enhanced
birth defects surveillance system to identify at least 200 eligible cases in the 33 county study area each year;
(b) Utilize birth certificates to identify an eligible sample of 100 control infants per year; (c) Conduct clinical
case review and classification by clinical geneticist and pediatric cardiologist; (d) Obtain consent from NC
participants for supplemental data collection including newborn blood spots and access to health care claims
data; and (e) Obtain residual newborn blood spots from the NC State Laboratory; (2) Collect information on
early pregnancy exposure to modifiable risk factors via a maternal telephone interview with a specific focus on
maternal chronic disease and their treatments, infectious disease in pregnancy, and medications; (3) Link
consented NC participants to the Electronic Disease Surveillance System to ascertain information about
reportable infections before and during pregnancy; (4) Develop innovative study proposals using NBDPS and
BD-STEPS data with maximum potential for public health impact, conduct rigorous analyses, present findings
at national meetings, and publish at least 10 papers during the 5-year award period; (5) Conduct a pilot study
to validate self-reported prescription medication use by linking case and control mothers with population-level
health care claims; (6) Conduct innovative laboratory research to develop methods for using residual newborn
blood spots to investigate potential genetic, epigenetic, and environmental risk factors for birth defects; (7)
Provide expertise on the application of epidemiologic, genetic/epigenetic, and biostatistical methods to birth
defects research; (8) Participate in collaborative research initiatives with other CBDRP and the CDC; and (9)
Continue to train the future generation of birth defect researche...

## Key facts

- **NIH application ID:** 9976393
- **Project number:** 5U01DD001231-03
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Tania A. Desrosiers
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2020
- **Award amount:** $900,000
- **Award type:** 5
- **Project period:** 2018-09-01 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9976393

## Citation

> US National Institutes of Health, RePORTER application 9976393, Component A: BD-STEPS II Core at North Carolina Center for Birth Defects Research and Prevention (NC BDSTEPS II Core) (5U01DD001231-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9976393. Licensed CC0.

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