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

NCT03494738 | Unknown

• 1 other identifier: 17-388
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Alcohol Spectrum Disorders

Keywords

Prenatal alcohol exposure

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours post birth

Secondary Outcomes (1)

• Optimal timing to obtain samples from neonates for prenatal alcohol detection

  48 hours post birth

Other Outcomes (3)

• Gestational age at birth

  at birth

• Small for gestational age: composite of small for gestational age (<10% percentile) for weight or length or head circumference

  at birth

• 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

Study Arms (1)

Newborn infants

Neonates born from consented women at the study hospital

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women will be consented for study participation of their neonates prior to delivery.

You may qualify if:

• 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

You may not qualify if:

• 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:
• Birth mother was consented prior to delivery
• Live birth at CAMC Women and Children's Hospital
• Birth mother was NOT consented prior to delivery
• Stillborn

Sponsors & Collaborators

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

Study Sites (1)

CAMC - Women and Children's Hospital

Charleston, West Virginia, 25302, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Dried bloodspots obtained from umbilical cord at birth and heel sticks at 24-48 hours post birth.

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Stefan Maxwell, MD

  CAMC Women and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of NICU, CAMC Women and Children's Hospital

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 11, 2018
• Study Start: April 12, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)