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NCT02557191 · ClinicalTrials.gov registry record

Biomarkers, Neurodevelopment and Preterm Infants

A clinical trial, sponsored by Montefiore Medical Center.

Terminated
Registry status
4
Enrollment target

NCT02557191: Clinical Trial study, sponsored by Montefiore Medical Center.

NCT02557191 is a clinical trial that was terminated before completion, run by Montefiore Medical Center. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02557191 was terminated before completion, sponsored by Montefiore Medical Center.

TERMINATED
Registry status
4 participants
Enrollment target

Study 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.

Primary Outcome

Brain MRI

Interventions

  • OTHER Observational study

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2015-04
Est. Completion 2018-12
Montefiore Medical Center

345 total trials

Why NCT02557191 stopped before completion

NCT02557191 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Observational study is the first listed.

NCT02557191 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02557191 about?

NCT02557191 is a clinical study titled "Biomarkers, Neurodevelopment and 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 co...

What is the current status of trial NCT02557191?

This trial is currently terminated. The enrollment target is 4 participants. The study started on 2015-04. Estimated completion is 2018-12.

What interventions are being tested in trial NCT02557191?

The interventions under investigation include: Observational study (OTHER).

Who is sponsoring clinical trial NCT02557191?

This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02557191, the US trial registry maintained by the National Library of Medicine. NCT02557191 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.