- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03722901
Neurophysiological Maturation Correlate With Clinical Milestones (NEMO)
October 25, 2018 updated by: Abbot Laptook, Women and Infants Hospital of Rhode Island
Neurophysiologic Maturation Index: The NEMO Project for Moderate and Late Preterm Infants
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- McGill University Health Center
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-
-
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 4 days (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Neonates
Description
Inclusion Criteria:
Preterm cohort:
- Gestational age of either 32 weeks or 34 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
Term Cohort:
- Gestational age of 39-40 weeks
- Care provided in a Newborn Nursery or rooming in with the mother
Exclusion Criteria:
Preterm Cohort:
- 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
Term Cohort:
- Any morbidity (eg, hypoglycemia [blood glucose < 40mg/dL] beyond 4 hours of age, abstinence, jaundice requiring phototherapy, sepsis evaluations which include obtaining blood cultures and initiation of antibiotics)
- Maternal complications of pregnancy (eg hypertension, diabetes mellitus, thyroid disorders, psychologic disorders requiring treatment with drugs such as SSRIs)
- Growth restriction (birth weight < 10%)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Late preterm infants
34 weeks and 0-6 days gestational age
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Moderate preterm infants
32 weeks and 0-6 days gestational age
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Reference
Term infants 9m/39-40
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variance between gestational age and time to reach clinical milestones for safe discharge among moderate and late preterm infants with and without neurophysiologic maturation
Time Frame: Hospital stay, 12 weeks
|
Magnitude of variance for the association between gestational age and time to wean to crib and to achieve full oral feeds among moderate and late preterm infants with and without the addition of aEEG and/or HRV measures
|
Hospital stay, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Abbot Laptook, MD, Women & Infants Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 5, 2013
Primary Completion (Actual)
May 2, 2017
Study Completion (Actual)
May 2, 2017
Study Registration Dates
First Submitted
October 23, 2018
First Submitted That Met QC Criteria
October 25, 2018
First Posted (Actual)
October 29, 2018
Study Record Updates
Last Update Posted (Actual)
October 29, 2018
Last Update Submitted That Met QC Criteria
October 25, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 792508-6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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