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

Sponsor
CAMC Health System (Other)
Overall Status
Unknown status
CT.gov ID
NCT03494738
Collaborator
United States Drug Testing Laboratories, Inc. (Other)
600
Enrollment
1
Location
23.7
Anticipated Duration (Months)
25.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development of an Epigenetic Biomarker for Prediction of Fetal Alcohol Spectrum Disorder
    Actual Study Start Date :
    Apr 12, 2018
    Anticipated Primary Completion Date :
    Apr 1, 2020
    Anticipated Study Completion Date :
    Apr 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Newborn infants

    Neonates born from consented women at the study hospital

    Outcome Measures

    Primary Outcome Measures

    1. Epigenetic changes as biomarkers of prenatal alcohol exposure [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.

    Secondary Outcome Measures

    1. Optimal timing to obtain samples from neonates for prenatal alcohol detection [48 hours post birth]

      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.

    Other Outcome Measures

    1. Gestational age at birth [at birth]

    2. Small for gestational age: composite of small for gestational age (<10% percentile) for weight or length or head circumference [at birth]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CAMC - Women and Children's Hospital Charleston West Virginia United States 25302

    Sponsors and Collaborators

    • CAMC Health System
    • United States Drug Testing Laboratories, Inc.

    Investigators

    • Principal Investigator: Stefan Maxwell, MD, CAMC Women and Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stefan Maxwell, Medical Director of NICU, CAMC Women and Children's Hospital, CAMC Health System
    ClinicalTrials.gov Identifier:
    NCT03494738
    Other Study ID Numbers:
    • 17-388
    First Posted:
    Apr 11, 2018
    Last Update Posted:
    May 22, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Stefan Maxwell, Medical Director of NICU, CAMC Women and Children's Hospital, CAMC Health System
    Prenatal alcohol exposure
    Additional relevant MeSH terms:
    Fetal Alcohol Spectrum Disorders

    Study Results

    No Results Posted as of May 22, 2019