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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Fetal Alcohol Spectrum Disorders

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newborn infants<br>Neonates born from consented women at the study hospital | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epigenetic changes as biomarkers of prenatal alcohol exposure | 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. | 48 hours post birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal timing to obtain samples from neonates for prenatal alcohol detection | 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. | 48 hours post birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prenatal alcohol exposure