Neurophysiologic Maturation Index for Moderate and Late Preterm Infants

Neurophysiologic Maturation Clinical Trial

— NEMO Project  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02156817
• Other study ID #: 13-0052
• Status: Recruiting
• Phase: N/A
• First received: May 17, 2014
• Last updated: June 2, 2014
• Start date: March 2014

Study information

• Verified date: June 2014
• Source: Brown University
• Contact: Birju A Shah, MD, MPH
• Phone: 401-274-1122
• Email: Birju_Shah[@]Brown.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 171
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Days

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neurophysiologic Maturation

Intervention

Other:
• Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisition

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec
United States	Wayne State University	Detroit	Michigan
United States	Brown University - Women and Infants Hospital of Rhode Island NICU	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	McGill University Health Center, Wayne State University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnitude of variance, R square	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	2 years	No
Secondary	Amplitude integrated electroencephalogram (aEEG)	number of cycles/hour, the lower border voltage, the span voltage or the percent of the tracing which is discontinuous	participants will be followed for the duration of hospital stay, an expected average of 5 weeks	No
Secondary	Heart rate variability (HRV)	standard deviation of the R-R interval, sample asymmetry and sample entropy	participants will be followed for the duration of hospital stay, an expected average of 5 weeks	No
Secondary	Respiratory variability (RV)	instantaneous respiratory effort, phase between ribcage and abdomen, amplitude of the signal, pause metrics and movement artifact metrics	participants will be followed for the duration of hospital stay, an expected average of 5 weeks	No