Biomarkers, Neurodevelopment and Preterm Infants

NCT ID: NCT02557191

Last Updated: 2019-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Preterm Neurodevelopmental Disorder Epigenetic Changes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Preterm infants \<32 weeks gestational age

Observational study

Intervention Type OTHER

Interventions

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Observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \<32 weeks" gestation
* Born at Weiler Division of Montefiore

Exclusion Criteria

* Intraventricular hemorrhage
* Chromosomal abnormalities
* Congenital viral conditions
Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albert Einstein College of Medicine

OTHER

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Mamta Fuloria

Associate Professor, Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mamta Fuloria, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Jack D. Weiler Hospital

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2015-4484

Identifier Type: -

Identifier Source: org_study_id

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