Clinical Trials Directory

Trials / Completed

CompletedNCT02156817

Neurophysiologic Maturation Index for Late Preterm Infants

Neurophysiologic Maturation Index: NEMO Project for Late Preterm Infants

Status
Completed
Phase
Study type
Observational
Enrollment
26 (actual)
Sponsor
Brown University · Academic / Other
Sex
All
Age
1 Day – 4 Days
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERAmplitude integrated electroencephalogram, Cardiorespiratory signal acquisition

Timeline

Start date
2014-03-01
Primary completion
2014-08-18
Completion
2017-06-02
First posted
2014-06-05
Last updated
2025-10-03

Locations

3 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT02156817. Inclusion in this directory is not an endorsement.