Biomarkers, Neurodevelopment and Preterm Infants

Preterm Clinical Trial

Official title:

Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02557191
• Other study ID #: 2015-4484
• Status: Terminated
• Start date: April 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Days

Eligibility

Inclusion Criteria:

• <32 weeks? gestation

• Born at Weiler Division of Montefiore

Exclusion Criteria:

• Intraventricular hemorrhage

• Chromosomal abnormalities

• Congenital viral conditions

Related Conditions & MeSH terms

• Epigenetic Changes
• Neurodevelopmental Disorder
• Neurodevelopmental Disorders
• Premature Birth
• Preterm

Intervention

Other:
• Observational study

Locations

Country	Name	City	State
United States	Jack D. Weiler Hospital	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain white matter development	Brain MRI	38-42 weeks adjusted age
Secondary	Neurodevelopment	Administration of NICU Neonatal Neurobehavioral Scale	38-42 weeks adjusted age
Secondary	Neurodevelopment	Administration of Bayley Scales of Infant and Toddler Development, 3rd edition	18-24 months adjusted age