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

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03494738
• Other study ID #: 17-388
• Status: Active, not recruiting
• Start date: April 12, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2022
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders

Locations

Country	Name	City	State
United States	CAMC - Women and Children's Hospital	Charleston	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
CAMC Health System	United States Drug Testing Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gestational age at birth		at birth
Other	Small for gestational age: composite of small for gestational age (<10% percentile) for weight or length or head circumference		at birth
Other	Postnatal complications: Composite of having one or more of the following: neonatal sepsis, necrotizing enterocolitis, respiratory distress syndrome, hyperbilirubinemia, intraventricular hemorrhage		28 days post birth
Primary	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	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