Development of an Epigenetic Biomarker for Prediction of... | NCT03494738

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

NCT03494738

Sponsor

CAMC Health System

Status

Unknown status

Last Update Posted

Sep 2, 2022Actual

Enrollment

600Actual

Phase

Not provided

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2018Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Mar 23, 2018

First Submission Date that Met QC Criteria

Apr 4, 2018

First Posted Date

Apr 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2022

Last Update Posted Date

Sep 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stefan Maxwell, Medical Director of NICU, CAMC Women and Children's Hospital, CAMC Health SystemPrincipal Investigator

Lead Sponsor

CAMC Health SystemOTHER

Collaborators

Name	Class
United States Drug Testing Laboratories, Inc.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Actual

Label	Type	Description	Intervention Names
Newborn infants		Neonates born from consented women at the study hospital

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Optimal timing to obtain samples from neonates for prenatal alcohol detection	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.	48 hours post birth

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Maxwell, MD	CAMC Women and Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CAMC - Women and Children's Hospital		Charleston	West Virginia	25302	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D063647	Fetal Alcohol Spectrum Disorders

Ancestor Terms

ID	Term
D005315	Fetal Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided