Skip to main content
Clinical Trials/NCT02557191
NCT02557191
Terminated
N/A

Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants

Montefiore Medical Center1 site in 1 country4 target enrollmentApril 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preterm
Sponsor
Montefiore Medical Center
Enrollment
4
Locations
1
Primary Endpoint
Brain white matter development
Status
Terminated
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
December 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mamta Fuloria

Associate Professor, Pediatrics

Montefiore Medical Center

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Intraventricular hemorrhage
  • Chromosomal abnormalities
  • Congenital viral conditions

Outcomes

Primary Outcomes

Brain white matter development

Time Frame: 38-42 weeks adjusted age

Brain MRI

Secondary Outcomes

  • Neurodevelopment(18-24 months adjusted age)

Study Sites (1)

Loading locations...

Similar Trials