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Completed NCT03494738

Development of an Epigenetic Biomarker for Prediction of Fetal Alcohol Spectrum Disorder

Conditions: Fetal Alcohol Spectrum Disorders

Sex: All
Healthy volunteers: No
Enrollment: 600
Sponsor: CAMC Health System

Location: CAMC - Women and Children's Hospital Charleston West Virginia

Summary

The objective of the study is to validate epigenetic changes as biomarkers in a prospective sampling of newborn blood samples collected at birth (umbilical cord blood) and during routine screening (heel stick blood) in newborns concurrently tested for alcohol exposure levels by PEth blood spot testing.

Eligibility Criteria

Women: Inclusion criteria * Women aged ≥ 18 years and currently pregnant at time of enrollment * Women who plan to and then deliver their infants at CAMC Women and Children's Hospital Exclusion criteria * Women aged \< 18 years * Women not pregnant * Women who do not plan to deliver or did not end up delivering their infants at CAMC Women and Children's Hospital Infants: Inclusion criteria * Birth mother was consented prior to delivery * Live birth at CAMC Women and Children's Hospital Exclusion criteria * Birth mother was NOT consented prior to delivery * Stillborn

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03494738). StuddyBuddy aggregates publicly available trial information.