Biomarkers, Neurodevelopment and Preterm Infants

Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants

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.

Study Overview

• Status: Terminated
• Conditions: Neurodevelopmental Disorder; Preterm; Epigenetic Changes
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Jack D. Weiler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Preterm infants <32 weeks GA

Description

Inclusion Criteria:

• <32 weeks" gestation
• Born at Weiler Division of Montefiore

Exclusion Criteria:

• Intraventricular hemorrhage
• Chromosomal abnormalities
• Congenital viral conditions

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Preterm infants <32 weeks gestational age	Other: Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain white matter development	Brain MRI	38-42 weeks adjusted age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurodevelopment	Administration of NICU Neonatal Neurobehavioral Scale	38-42 weeks adjusted age
Neurodevelopment	Administration of Bayley Scales of Infant and Toddler Development, 3rd edition	18-24 months adjusted age

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Albert Einstein College of Medicine
• Investigators: Principal Investigator: Mamta Fuloria, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: September 21, 2015
• First Posted (Estimate): September 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Neurodevelopmental Disorders
• Other Study ID Numbers: 2015-4484

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No