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