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Neurophysiologic Maturation Index for Late Preterm Infants

NCT02156817 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2025-10-03

No results posted yet for this 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.

Conditions

  • Neurophysiologic Maturation

Interventions

OTHER

Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisition

Sponsors & Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • Wayne State University

    collaborator OTHER

  • Brown University

    lead OTHER

Principal Investigators

  • Birju A Shah, MD, MPH · Brown University - Women and Infants Hospital of Rhode Island

  • Abbot Laptook, MD · Brown University - Women and Infants Hospital of Rhode Island

Eligibility

Min Age
1 Day
Max Age
4 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-08-18
Completion
2017-06-02

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02156817 on ClinicalTrials.gov