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Completed

NCT Number: NCT02156817

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 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.

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Key information

Age range

1 day–4 day

Sex eligibility

All sexes

Study type

Observational

Primary location

McGill University Health Center, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age of 340-346 weeks by Obstetric criteria (presence of a sure LMP or sonogram performed in the first trimester, or agreement between LMP and a sonogram performed between the first trimester and 20 weeks)
  • Admitted to a NICU of a participating institution
  • Post-natal age less than 96 hours

Exclusion criteria

  • Major congenital anomaly/genetic anomaly
  • Growth restriction (birth weight < 10%, Fenton growth curves)
  • Unsure obstetric dating (e.g., absence of a sure LMP without a sonogram, earliest sonogram performed after 20 weeks without a sure LMP, or discrepancy between LMP and sonogram)
  • Exposure to medications within the preceding 12 hrs which may affect CNS function (e.g., fentanyl, morphine, midazolam)
  • Neonatal seizures
  • Neonatal abstinence syndrome secondary to in-utero exposure to narcotics, methadone etc, or at high risk for development of abstinence
  • Hypoxia-ischemia defined as the combination of fetal acidemia (cord gas or blood gas within 1 hour of birth: pH ≤ 7.15 or BE ≥ -10mEq/L), need for resuscitation at birth (PPV ± chest compressions or medications), and evidence of encephalopathy (Stage 1, 2 or 3 Sarnat). Stage 1 encephalopathy will be defined based on the level of consciousness which is characterized by a hyper-alert state, apparent alertness, and irritability. In the absence of a cord or early post-natal blood gas, there must be a history of a perinatal event which may have compromised oxygenation or blood flow to the fetus.
  • Infants who are expected to be on mechanical (via an endotracheal tube) or high frequency ventilation for the first 96 hours after birth.
  • Inability to obtain the informed consent

Treatment and study plan

Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisition

Other

Primary outcomes

  1. Magnitude of variance, R square

    Time frame: 2 years

    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

Secondary outcomes

  1. Amplitude integrated electroencephalogram (aEEG)

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks

    number of cycles/hour, the lower border voltage, the span voltage or the percent of the tracing which is discontinuous

  2. Heart rate variability (HRV)

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks

    standard deviation of the R-R interval, sample asymmetry and sample entropy

  3. Respiratory variability (RV)

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks

    instantaneous respiratory effort, phase between ribcage and abdomen, amplitude of the signal, pause metrics and movement artifact metrics

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

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

Registry information

Official study title

Neurophysiologic Maturation Index: NEMO Project for Late Preterm Infants

Acronym: NEMO Project

Important dates

Study start
2014
Primary completion
2014
Study completion
2017
First posted
Jun 5, 2014
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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