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

Active, not recruiting

• Conditions: Fetal Alcohol Spectrum Disorders

• Registration Number: NCT03494738
• Lead Sponsor: CAMC Health System

Brief 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.

Detailed Description

Fetal alcohol spectrum disorders (FASD) are a group of conditions that can occur in a person whose birth mother consumed alcohol during pregnancy. The effects can include physical problems and/or difficulties with behavior and learning. When clinicians identify FASD early, intervention approaches can minimize the potential impact and lessen or even prevent disabilities. Thus, objective markers for prenatal alcohol exposure are desired.

Using dried blood spots from the umbilical cord and a heel stick of newborns, this study will use Phosphatidylethanol (PEth), a novel biomarker for alcohol exposure, to identify and characterize infants' exposure to alcohol before birth. Additionally, the dried blood spots will used to validate the use of screening assays using epigenetic changes as markers for prenatal alcohol exposure. Epigenetic changes are heritable changes in DNA that affect DNA function but do not change DNA sequence. The use of PEth testing will allow for the correlation of prenatal alcohol exposure levels with epigenetic changes. Women will be consented prior to delivery for participation in this prospective study. The study will be conducted in collaboration with United States Drug Testing Laboratories, Inc. (USDTL).

Study Timeline

• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-11
• Study Start: 2018-04-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-02
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epigenetic changes as biomarkers of prenatal alcohol exposure	48 hours post birth	Validation of the epigenetic changes as biomarkers 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.

Secondary Outcome Measures

Name	Time	Method
Optimal timing to obtain samples from neonates for prenatal alcohol detection	48 hours post birth	To compare PEth levels and epigenetic changes in dried blood spots obtained via umbilical cord at birth verses heel stick at 48 hours post-birth.

Trial Locations

Locations (1)

CAMC - Women and Children's Hospital; 🇺🇸 Charleston, West Virginia, United States