NCT03722901

Neurophysiological Maturation Correlate With Clinical Milestones

Neurophysiologic Maturation Index: The NEMO Project for Moderate and Late Preterm Infants

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: All
• Age: 4 Days
• Healthy volunteers: Not accepted

Summary

To examine the association of early measures of heart rate variability and amplitude-integrated electroencephalography with time to wean to crib and to achieve full oral feeds among moderate and late preterm infants.

Detailed description

Moderate and 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 in this population are understudied. Gestational age is used most commonly as a predictor for length of hospital stay 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). Both non-invasive tests that can be done at the bedside. The study hypothesis is to determine if neurophysiologic maturation as assessed by aEEG and HRV within 24-96 hours following birth improves the correlation between gestational age and time to reach milestones for safe discharge, such as thermal regulation and oral-motor skills for adequate nutritional intake, compared to gestational age alone.

Conditions

• Neurophysiologic Maturation

Timeline

• Start date: 2013-08-05
• Primary completion: 2017-05-02
• Completion: 2017-05-02
• First posted: 2018-10-29
• Last updated: 2018-10-29

Locations

2 sites across 2 countries: United States, Canada