Ignite Creation Date:
2024-05-06 @ 7:34 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02557191
Status:
TERMINATED
Last Update Posted:
2019-04-25
First Post:
2015-07-06
Brief Title:
Biomarkers Neurodevelopment and Preterm Infants
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty recruiting patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None