Biomarkers, Neurodevelopment and Preterm Infants | NCT02557191

Studies
Biomarkers, Neurodevelopment and Preterm Infants

NCT02557191

Sponsor

Montefiore Medical Center

Status

Terminated

Last Update Posted

Apr 25, 2019Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Preterm
Neurodevelopmental Disorder
Epigenetic Changes

Interventions

Observational study

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

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty recruiting patients

Expanded Access Info

Start Date

Apr 2015Actual

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Jul 6, 2015

First Submission Date that Met QC Criteria

Sep 21, 2015

First Posted Date

Sep 23, 2015Estimated

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

Apr 23, 2019

Last Update Posted Date

Apr 25, 2019Actual

Name	Class
Albert Einstein College of Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Approximately 2% of neonates in the US are born very preterm. Preterm births are associated with impaired cognitive, language and motor function, and increased risk for autism spectrum disorders. Epidemiological studies indicate a dose-response relationship between gestational age at delivery and cognitive impairments, with the most immature of newborns being the most susceptible to developmental delays. Sensitive and reproducible biomarkers of long-term neurocognitive impairments are currently lacking. The investigators seek to identify epigenetic markers that mediate the relationship between adverse prematurity-related exposures and neurocognitive impairments. The overarching hypothesis of this proposal is that DNA methylation profiles of CD34+ hematopoetic progenitor and stem cells from very preterm infants can be used as a risk-stratifying biomarker for predicting neurocognitive impairment in childhood.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Preterm infants <32 weeks gestational age	Other: Observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational study	Other		Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brain white matter development	Brain MRI	38-42 weeks adjusted age

Secondary Outcomes

Measure	Description	Time Frame
Neurodevelopment	Administration of NICU Neonatal Neurobehavioral Scale	38-42 weeks adjusted age
Neurodevelopment	Administration of Bayley Scales of Infant and Toddler Development, 3rd edition

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

<32 weeks" gestation
Born at Weiler Division of Montefiore

Exclusion Criteria:

Intraventricular hemorrhage
Chromosomal abnormalities
Congenital viral conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

2 Days

Standard Ages

Child

Study Population

Preterm infants <32 weeks GA

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mamta Fuloria, MD	Montefiore Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jack D. Weiler Hospital		The Bronx	New York	10461	United States

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D065886	Neurodevelopmental Disorders

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided