NCT02557191

Biomarkers, Neurodevelopment and Preterm Infants

Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 1 Day – 2 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm
• Neurodevelopmental Disorder
• Epigenetic Changes

Interventions

Type	Name	Description
OTHER	Observational study

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2015-09-23
• Last updated: 2019-04-25

Locations

1 site across 1 country: United States