Development of an Epigenetic Biomarker for Prediction of Fetal Alcohol Spectrum Disorder
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|ClinicalTrials.gov Identifier: NCT03494738|
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : May 22, 2019
|Condition or disease|
|Fetal Alcohol Spectrum Disorders|
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 Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Development of an Epigenetic Biomarker for Prediction of Fetal Alcohol Spectrum Disorder|
|Actual Study Start Date :||April 12, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Neonates born from consented women at the study hospital
- 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.
- Optimal timing to obtain samples from neonates for prenatal alcohol detection [ Time Frame: 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.
- 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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494738
|Contact: Stefan Maxwell, MDfirstname.lastname@example.org|
|United States, West Virginia|
|CAMC - Women and Children's Hospital||Recruiting|
|Charleston, West Virginia, United States, 25302|
|Principal Investigator:||Stefan Maxwell, MD||CAMC Women and Children's Hospital|