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Trial record 13 of 36 for:    fetal alcohol children

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
Sponsor:
Collaborator:
United States Drug Testing Laboratories, Inc.
Information provided by (Responsible Party):
Stefan Maxwell, CAMC Health System

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
Fetal Alcohol Spectrum Disorders

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).


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Study Type : Observational
Estimated 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 : April 12, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Newborn infants
Neonates born from consented women at the study hospital



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Gestational age at birth [ Time Frame: at birth ]
  2. Small for gestational age: composite of small for gestational age (<10% percentile) for weight or length or head circumference [ Time Frame: at birth ]
  3. 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
Dried bloodspots obtained from umbilical cord at birth and heel sticks at 24-48 hours post birth.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women will be consented for study participation of their neonates prior to delivery.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Stefan Maxwell, MD 304-388-2238 neodoc1124@gmail.com

Locations
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United States, West Virginia
CAMC - Women and Children's Hospital Recruiting
Charleston, West Virginia, United States, 25302
Sponsors and Collaborators
CAMC Health System
United States Drug Testing Laboratories, Inc.
Investigators
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Principal Investigator: Stefan Maxwell, MD CAMC Women and Children's Hospital

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Responsible Party: Stefan Maxwell, Medical Director of NICU, CAMC Women and Children's Hospital, CAMC Health System
ClinicalTrials.gov Identifier: NCT03494738     History of Changes
Other Study ID Numbers: 17-388
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stefan Maxwell, CAMC Health System:
Prenatal alcohol exposure

Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Fetal Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Disease
Pathologic Processes
Pregnancy Complications
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs