Clinical trial NCT03494738: Development of an Epigenetic Biomarker for Prediction of Fetal Alcohol Spectrum Disorder
Official title: Development of an Epigenetic Biomarker for Prediction of Fetal Alcohol Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Alcohol Spectrum Disorders
Keywords: Prenatal alcohol exposure
Lead sponsor: CAMC Health System
Sponsor class: OTHER
Collaborators: name: United States Drug Testing Laboratories, Inc.
First posted: 2018-04-11
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women will be consented for study participation of their neonates prior to delivery.

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Epigenetic changes as biomarkers of prenatal alcohol exposure
timeFrame: 48 hours post birth
Secondary outcomes:
measure: Optimal timing to obtain samples from neonates for prenatal alcohol detection
timeFrame: 48 hours post birth
Other outcomes:
measure: Gestational age at birth
timeFrame: at birth
measure: Small for gestational age: composite of small for gestational age (<10% percentile) for weight or length or head circumference
timeFrame: at birth
measure: Postnatal complications: Composite of having one or more of the following: neonatal sepsis, necrotizing enterocolitis, respiratory distress syndrome, hyperbilirubinemia, intraventricular hemorrhage
timeFrame: 28 days post birth
Locations:
city: Charleston
country: United States
facility: CAMC - Women and Children's Hospital
state: West Virginia
Study officials:
affiliation: CAMC Women and Children's Hospital
name: Stefan Maxwell, MD
role: PRINCIPAL_INVESTIGATOR
References: