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
| Type | Name | Description |
|---|---|---|
| OTHER | Amplitude 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.