Fetal Alcohol Spectrum DisordersNCT03494738
Development of an Epigenetic Biomarker for Prediction of Fetal Alcohol Spectrum Disorder
An observational study of Fetal Alcohol Spectrum Disorders, run by CAMC Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2018to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women will be consented for study participation of their neonates prior to delivery.
Who may be able to join
- 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
- Birth mother was consented prior to delivery
- Live birth at CAMC Women and Children's Hospital
Who cannot join
- 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:
- Birth mother was NOT consented prior to delivery
- Stillborn
Trial locations and contacts
1 site in 1 country.
United States1 site
CAMC - Women and Children's Hospital
Charleston, West Virginia, 25302
About this study
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.
Read the 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).
- Conditions
- Fetal Alcohol Spectrum Disorders
- Keywords
- Prenatal alcohol exposure
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Newborn infants | Neonates born from consented women at the study hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours post birth
Secondary outcomes (1)
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.
Measured: 48 hours post birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start12 Apr 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Maxwell, MD, Principal investigator, CAMC Women and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494738
- Sponsor's protocol ID
- 17-388
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2018
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Epigenetic Biomarker for Prediction of Fetal Alcohol Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03494738
- Acronym / sponsor ID
- 17-388
- Conditions
- Fetal Alcohol Spectrum Disorders
- Keywords
- Prenatal alcohol exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborn infants | – | –Neonates born from consented women at the study hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women will be consented for study participation of their neonates prior to delivery.
Key inclusion criteria (4 listed)
- 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
- Birth mother was consented prior to delivery
- Live birth at CAMC Women and Children's Hospital
Key exclusion criteria (6 listed)
- 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
- Birth mother was NOT consented prior to delivery
- Stillborn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epigenetic changes as biomarkers of prenatal alcohol exposure
Time frame: 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.
1 secondary outcome
Optimal timing to obtain samples from neonates for prenatal alcohol detection
Time frame: 48 hours post birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Maxwell, MD principal investigator
CAMC Women and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Alcohol Spectrum Disorders, run by CAMC Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic changes as biomarkers of prenatal alcohol exposure (time frame: 48 hours post birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.