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A drop of blood may reveal hidden prenatal alcohol exposure

NCT ID NCT03494738

Knowledge-focused Sponsor: CAMC Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study is testing whether epigenetic changes in newborn blood can serve as a biomarker for fetal alcohol spectrum disorder (FASD). Researchers will collect umbilical cord blood at birth and heel stick blood at 48 hours from 600 newborns, and compare these with blood alcohol levels measured by PEth testing. The goal is to validate these epigenetic changes as a reliable indicator of prenatal alcohol exposure, which could lead to earlier detection and intervention for affected children.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Epigenetic biomarker testing on umbilical cord and heel stick blood samples
What this could lead to
If successful, this could lead to a reliable blood test to identify newborns exposed to alcohol before birth, enabling earlier support and intervention.
What could go wrong
The study is observational and early-stage, so the biomarker may not prove accurate enough for clinical use. Also, epigenetic changes can be influenced by many factors beyond alcohol.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

600 people

The number who actually took part.

Started

Apr 2018

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women will be consented for study participation of their neonates prior to delivery.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

fetal alcohol spectrum disorder fetal alcohol syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fetal alcohol spectrum disorders

Contacts and locations

Locations

  • CAMC - Women and Children's Hospital

    Charleston, West Virginia, 25302, United States

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