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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

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.

Condition or disease Intervention/treatment
Preterm Neurodevelopmental Disorder Epigenetic Changes Other: Observational study

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Study Type : Observational [Patient Registry]
Actual Enrollment : 4 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants
Actual Study Start Date : April 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

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

Primary Outcome Measures :
  1. Brain white matter development [ Time Frame: 38-42 weeks adjusted age ]
    Brain MRI

Secondary Outcome Measures :
  1. Neurodevelopment [ Time Frame: 38-42 weeks adjusted age ]
    Administration of NICU Neonatal Neurobehavioral Scale

  2. Neurodevelopment [ Time Frame: 18-24 months adjusted age ]
    Administration of Bayley Scales of Infant and Toddler Development, 3rd edition

Biospecimen Retention:   Samples With DNA
Cord blood, buccal swab and urine samples will be collected from enrolled patients.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Preterm infants <32 weeks GA

Inclusion Criteria:

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

Exclusion Criteria:

  • Intraventricular hemorrhage
  • Chromosomal abnormalities
  • Congenital viral conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02557191

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United States, New York
Jack D. Weiler Hospital
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Albert Einstein College of Medicine
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Principal Investigator: Mamta Fuloria, MD Montefiore Medical Center
Additional Information:

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Responsible Party: Mamta Fuloria, Associate Professor, Pediatrics, Montefiore Medical Center Identifier: NCT02557191    
Other Study ID Numbers: 2015-4484
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Premature Birth
Neurodevelopmental Disorders
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Mental Disorders