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Biomarkers, Neurodevelopment and Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02557191
Recruitment Status : Terminated (Difficulty recruiting patients)
First Posted : September 23, 2015
Last Update Posted : April 25, 2019
Albert Einstein College of Medicine
Information provided by (Responsible Party):
Mamta Fuloria, Montefiore Medical Center

Tracking Information
First Submitted Date July 6, 2015
First Posted Date September 23, 2015
Last Update Posted Date April 25, 2019
Actual Study Start Date April 2015
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2015)
Brain white matter development [ Time Frame: 38-42 weeks adjusted age ]
Brain MRI
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 21, 2015)
  • Neurodevelopment [ Time Frame: 38-42 weeks adjusted age ]
    Administration of NICU Neonatal Neurobehavioral Scale
  • Neurodevelopment [ Time Frame: 18-24 months adjusted age ]
    Administration of Bayley Scales of Infant and Toddler Development, 3rd edition
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Biomarkers, Neurodevelopment and Preterm Infants
Official Title Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants
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 Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Retention:   Samples With DNA
Cord blood, buccal swab and urine samples will be collected from enrolled patients.
Sampling Method Probability Sample
Study Population Preterm infants <32 weeks GA
  • Preterm
  • Neurodevelopmental Disorder
  • Epigenetic Changes
Intervention Other: Observational study
Study Groups/Cohorts Group 1
Preterm infants <32 weeks gestational age
Intervention: Other: Observational study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: April 23, 2019)
Original Estimated Enrollment
 (submitted: September 21, 2015)
Actual Study Completion Date December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Intraventricular hemorrhage
  • Chromosomal abnormalities
  • Congenital viral conditions
Sexes Eligible for Study: All
Ages up to 2 Days   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT02557191
Other Study ID Numbers 2015-4484
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mamta Fuloria, Montefiore Medical Center
Study Sponsor Montefiore Medical Center
Collaborators Albert Einstein College of Medicine
Principal Investigator: Mamta Fuloria, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date April 2019