UnknownNot Applicable

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

United States600 participantsStarted 2018-04-12

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Epigenetic changes as biomarkers of prenatal alcohol exposure

Timeframe: 48 hours post birth

Trial details

NCT IDNCT03494738

SponsorCAMC Health System

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Fetal Alcohol Spectrum Disorders trials