Biomarkers, Neurodevelopment and Preterm Infants

NCT02557191 | Terminated

• 1 other identifier: 2015-4484
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm; Neurodevelopmental Disorder; Epigenetic Changes

Outcome Measures

Primary Outcomes (1)

• Brain white matter development

  Brain MRI

  38-42 weeks adjusted age

Secondary Outcomes (2)

• Neurodevelopment

  38-42 weeks adjusted age

• Neurodevelopment

  18-24 months adjusted age

Study Arms (1)

Group 1

Preterm infants \<32 weeks gestational age

Other: Observational study

Interventions

Observational study OTHER

Group 1

Eligibility Criteria

• Age: 1 Day - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm infants \<32 weeks GA

You may qualify if:

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

You may not qualify if:

• Intraventricular hemorrhage
• Chromosomal abnormalities
• Congenital viral conditions

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Albert Einstein College of Medicine: collaborator

Study Sites (1)

Jack D. Weiler Hospital

The Bronx, New York, 10461, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cord blood, buccal swab and urine samples will be collected from enrolled patients.

MeSH Terms

Conditions

Premature Birth; Neurodevelopmental Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Mamta Fuloria, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatrics

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: September 23, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

US (1)