An observational study in Fetal Alcohol Spectrum Disorders, sponsored by CAMC Health System. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by CAMC Health System · Observational
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Among 36 studies in Fetal Alcohol Spectrum Disorders with a site in United States — 9 open to participants now, 10 under way, none of them phase 3. Fetal Alcohol Spectrum Disorders · United States.
Among the 36 studies in Fetal Alcohol Spectrum Disorders with a site in United States, this one is one of 3 that started in 2018, is one of 3 observational ones, and was the 18th registered.
65 studies on the registry are indexed under Fetal Alcohol Spectrum Disorders; 13 are open to participants now.
Browse Fetal Alcohol Spectrum Disorders studies →9 of the 36 studies in Fetal Alcohol Spectrum Disorders with a site in United States are open now. Recruiting first, the newest first:
University of Virginia · Sites in United States
Ages 18–44 · Women only · Healthy volunteers
University of Rochester · Sites in United States
Ages 18–25
University of California, Los Angeles · Sites in United States
Ages 8–12
University of Rochester · Sites in United States
Ages 18+
University of Rochester · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Fetal Alcohol Spectrum Disorders studies recruiting now, 4 (36%) set no upper age limit and 7 (64%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
36 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 8 · Phase 3 1
First in 2001; this study’s year is marked. 3 started in 2018.
Median enrollment 95 across the 33 interventional studies, 751 across the 3 observational. Of the 26 that completed or were terminated, 10 (38%) have results posted.
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None of the 36 has an industry lead sponsor. The 10 most frequent:
CAMC Health System is the lead sponsor of 47 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
CAMC Health System has 1 study filed under Fetal Alcohol Spectrum Disorders — fewer than ten, so there is no comparison to draw.
5 of the studies in Fetal Alcohol Spectrum Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06847165University of California, Los AngelesTrigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure | 2026-12-29 |
| NCT06638463University of RochesterMy Health Coach App RCT | 2026-12-31 |
| NCT05960461University of RochesterFamilies Moving Forward (FMF) Connect Pro for Mental Health Providers | 2027-04-30 |
| NCT05456321University of MinnesotaCIFASD 5 tDCS and Cognitive Training | 2027-05-31 |
| NCT05108974Jeff WozniakCholine Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study | 2027-07-31 |
Add all 5 to your calendar (.ics) → With an account.
Among the 36 studies in Fetal Alcohol Spectrum Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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).
Women will be consented for study participation of their neonates prior to delivery.
Women:
Inclusion criteria
Exclusion criteria
Infants:
Inclusion criteria
Exclusion criteria
Neonates born from consented women at the study hospital
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.
Time frame: 48 hours post birth
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.
Time frame: 48 hours post birth
Gestational age at birth
Time frame: at birth
Small for gestational age: composite of small for gestational age (<10% percentile) for weight or length or head circumference
Time frame: at birth
Postnatal complications: Composite of having one or more of the following: neonatal sepsis, necrotizing enterocolitis, respiratory distress syndrome, hyperbilirubinemia, intraventricular hemorrhage
Time frame: 28 days post birth
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Dec 2022, 56 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Fetal Alcohol Spectrum Disorders →
CAMC Health System