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Related Experiment Video

Updated: May 7, 2026

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale

Published on: August 25, 2014

The National Birth Defects Prevention Study: how to communicate data.

Anthony R Scialli¹

¹Tetra Tech Sciences, 2200 Wilson Blvd Ste 400, Arlington, VA 22201, USA.

Seminars in Fetal & Neonatal Medicine

|October 8, 2013

Summary

The National Birth Defects Prevention Study investigated potential causes of birth defects. One analysis found a possible link between ondansetron medication and cleft palate, though chance remains a possibility.

Keywords:

Case–control studies Causality Cleft palate Epidemiology Teratology

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Area of Science:

Reproductive health
Pediatric health
Epidemiology

Background:

The National Birth Defects Prevention Study is a population-based case-control study.
It investigates children with 34 specified types of malformations.
Mothers of affected and unaffected children are interviewed regarding lifestyle and exposures.

Purpose of the Study:

To identify potential risk factors for birth defects.
To explore associations between maternal exposures and specific malformations.
To evaluate the evidence for causation.

Main Methods:

Case-control study design.
Interviews with mothers of children with and without birth defects.
Statistical analysis to determine odds ratios for various exposures.

Main Results:

A large number of studies have been published from the data.
One study identified an increased odds ratio for ondansetron use in mothers of children with cleft palate.
Chance is considered a possible explanation for this specific association.

Conclusions:

Associations between exposures and birth defects require careful evaluation.
The ondansetron-cleft palate association warrants further investigation, considering potential confounding factors.
Systematic evaluation using established criteria (e.g., Hill criteria) is crucial for assessing teratogenic causation.