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.
Brief Title
Biomarkers, Neurodevelopment and Preterm Infants
Categories
Completion Date
Completion Date Type
Actual
Conditions
Preterm
Neurodevelopmental Disorder
Epigenetic Changes
Eligibility Criteria
Inclusion Criteria:
* \<32 weeks" gestation
* Born at Weiler Division of Montefiore
Exclusion Criteria:
* Intraventricular hemorrhage
* Chromosomal abnormalities
* Congenital viral conditions
* \<32 weeks" gestation
* Born at Weiler Division of Montefiore
Exclusion Criteria:
* Intraventricular hemorrhage
* Chromosomal abnormalities
* Congenital viral conditions
Inclusion Criteria
Inclusion Criteria:
* \<32 weeks" gestation
* Born at Weiler Division of Montefiore
* \<32 weeks" gestation
* Born at Weiler Division of Montefiore
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
2 Days
Minimum Age
1 Day
NCT Id
NCT02557191
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2015-4484
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants
Primary Outcomes
Outcome Description
Brain MRI
Outcome Measure
Brain white matter development
Outcome Time Frame
38-42 weeks adjusted age
Secondary Outcomes
Outcome Description
Administration of NICU Neonatal Neurobehavioral Scale
Outcome Time Frame
38-42 weeks adjusted age
Outcome Measure
Neurodevelopment
Outcome Description
Administration of Bayley Scales of Infant and Toddler Development, 3rd edition
Outcome Time Frame
18-24 months adjusted age
Outcome Measure
Neurodevelopment
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Preterm infants \<32 weeks GA
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
0
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mamta Fuloria
Investigator Email
MFULORIA@montefiore.org
Investigator Phone
718-904-2821