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Biomarkers, Neurodevelopment and Preterm Infants

Terminated
Conditions
Preterm
Neurodevelopmental Disorder
Epigenetic Changes
Interventions
Other: Observational study
Registration Number
NCT02557191
Lead Sponsor
Montefiore Medical Center
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 available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
4
Inclusion Criteria
  • <32 weeks" gestation
  • Born at Weiler Division of Montefiore
Exclusion Criteria
  • Intraventricular hemorrhage
  • Chromosomal abnormalities
  • Congenital viral conditions

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Group 1Observational studyPreterm infants \<32 weeks gestational age
Primary Outcome Measures
NameTimeMethod
Brain white matter development38-42 weeks adjusted age

Brain MRI

Secondary Outcome Measures
NameTimeMethod
Neurodevelopment18-24 months adjusted age

Administration of Bayley Scales of Infant and Toddler Development, 3rd edition

Trial Locations

Locations (1)

Jack D. Weiler Hospital

🇺🇸

Bronx, New York, United States

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