Clinical trial NCT02156817: Neurophysiologic Maturation Index for Moderate and Late Preterm Infants
Official title: Neurophysiologic Maturation Index: NEMO Project for Moderate and Late Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurophysiologic Maturation
Keywords: Amplitude integrated electroencephalogram
Heart rate variability
Respiratory rate variability
Preterm Infants
Length of Hospital Stay
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Wayne State University
First posted: 2014-06-05
Enrollment: 171
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonatal intensive care unit Newborn nursery

Brief summary: 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 (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.


Eligibility criteria: Inclusion Criteria:

* Gestational age of either 320-326 weeks or 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

Primary outcomes:
measure: Magnitude of variance, R square
timeFrame: 2 years
Secondary outcomes:
measure: Amplitude integrated electroencephalogram (aEEG)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
measure: Heart rate variability (HRV)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
measure: Respiratory variability (RV)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Providence
country: United States
facility: Brown University - Women and Infants Hospital of Rhode Island NICU
state: Rhode Island
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
affiliation: Brown University - Women and Infants Hospital of Rhode Island
name: Birju A Shah, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University - Women and Infants Hospital of Rhode Island
name: Abbot Laptook, MD
role: PRINCIPAL_INVESTIGATOR
References: