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NCT02156817 · ClinicalTrials.gov registry record

Neurophysiologic Maturation Index for Late Preterm Infants

A clinical trial, sponsored by Brown University.

Completed
Registry status
26
Enrollment target

NCT02156817: Completed study, sponsored by Brown University.

NCT02156817 is a clinical trial that has completed, run by Brown University. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02156817 has completed, sponsored by Brown University.

COMPLETED
Registry status
26 participants
Enrollment target

Study Summary

Late preterm infants contribute to significant neonatal intensive care unit health care resource utilization because of their sheer numbers. Determinants of the length of hospitalization (LOH) in this population are understudied. Gestational age (GA) is used most commonly as a predictor for LOH but there are many limitations including inaccurate dating and morbidities of prematurity which at least partly related to neurophysiological immaturity. The latter can be assessed by amplitude integrated electroencephalogram (aEEG, a simplified 5 lead EEG), and possibly by heart rate variability (HRV) and respiratory variability (RV). All 3 are non-invasive tests that can be done at the bedside. Our study hypothesis is to determine if neurophysiologic maturation as assessed by aEEG, HRV and RV within 24-96 hours following birth improves the correlation between gestational age and length of hospitalization compared to gestational age alone.

Primary Outcome

linear regression model: LOH = intercept + b1GA + b2aEEG + b3HRV + b4RV + error term; b1 - b4 represents the weight of each variable to explain the variance of the equation (R2), GA is gestational age, aEEG is amplitude integrated EEG, HRV is heart rate variability, RV is respiratory variability, LOH is length of hospital stay

Interventions

  • OTHER Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisition

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2014-03
Est. Completion 2017-06-02
Brown University

231 total trials

What the finished NCT02156817 record still lists

NCT02156817 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 26 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisition is the first listed.

NCT02156817 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02156817 about?

NCT02156817 is a clinical study titled "Neurophysiologic Maturation Index for Late Preterm Infants". Late preterm infants contribute to significant neonatal intensive care unit health care resource utilization because of their sheer numbers. Determinants of the length of hospitalization (LOH) in this population are understudied. Gestational age (GA) is used most commonly as a predictor for LOH but ...

What is the current status of trial NCT02156817?

This trial is currently completed. The enrollment target is 26 participants. The study started on 2014-03. Estimated completion is 2017-06-02.

What interventions are being tested in trial NCT02156817?

The interventions under investigation include: Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisition (OTHER).

Who is sponsoring clinical trial NCT02156817?

This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02156817, the US trial registry maintained by the National Library of Medicine. NCT02156817 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.