Fetal Alcohol Spectrum Disorders
Conditions
Keywords
Prenatal alcohol exposure
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).
Interventions
None listed
Sponsors
CAMC Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStefan Maxwell, MD
CAMC Women and Children's Hospital
Outcome results
None listed