Neurophysiologic MaturationNEMO ProjectNCT02156817
Neurophysiologic Maturation Index for Late Preterm Infants
An observational study of Neurophysiologic Maturation, run by Brown University at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 4 days
- Conditions the study is for
- Neurophysiologic Maturation
- What is being tested?
- Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisition
- How many people
- 26 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2014to 2 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 4 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonatal intensive care unit Newborn nursery
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Wayne State University
Detroit, Michigan, 48201
Brown University - Women and Infants Hospital of Rhode Island NICU
Providence, Rhode Island, 02905
About this study
Official title: Neurophysiologic Maturation Index: NEMO Project 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.
- Conditions
- Neurophysiologic Maturation
- Being tested
- Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisition
- Keywords
- Amplitude integrated electroencephalogram, Heart rate variability, Respiratory rate variability, Preterm Infants, Length of Hospital Stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisitionOther
| Study group | Role | What they receive |
|---|---|---|
| Late Preterm Infants (LPT) | 34 weeks and 0-6 days gestational age Receives: Other: Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (3)
Amplitude integrated electroencephalogram (aEEG)
number of cycles/hour, the lower border voltage, the span voltage or the percent of the tracing which is discontinuous
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Heart rate variability (HRV)
standard deviation of the R-R interval, sample asymmetry and sample entropy
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Respiratory variability (RV)
instantaneous respiratory effort, phase between ribcage and abdomen, amplitude of the signal, pause metrics and movement artifact metrics
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMar 2014
- Primary completion18 Aug 2014
- Study completion2 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurophysiologic MaturationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Wayne State University
- Responsible party
- Principal investigator, Birju A. Shah, MD MPH, University of Oklahoma
- Investigators
- Birju A Shah, MD, MPH, Principal investigator, Brown University - Women and Infants Hospital of Rhode IslandAbbot Laptook, MD, Principal investigator, Brown University - Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156817
- Sponsor's protocol ID
- 13-0052
- Acronym
- NEMO Project
- Status last verified
- Sep 2025
- First submitted
- 17 May 2014
- Last updated
- 3 Oct 2025
- Results posted
- No
Publications
Shah BA, Latremouille S, Chawla S, Keszler M, Tucker R, Laptook A, Sant'anna GM. Heart rate variability and amplitude-integrated electroencephalography measured shortly after birth and time to reach clinical milestones: a pilot study in late preterm infants. Front Pediatr. 2025 Jun 5;13:1579197. doi: 10.3389/fped.2025.1579197. eCollection 2025.
PubMed 40538931
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiologic Maturation Index: NEMO Project for Late Preterm Infants
- ClinicalTrials.gov ID
- NCT02156817
- Acronym / sponsor ID
- NEMO Project / 13-0052
- Conditions
- Neurophysiologic Maturation
- Keywords
- Amplitude integrated electroencephalogram, Heart rate variability, Respiratory rate variability, Preterm Infants, Length of Hospital Stay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Wayne State University
- Study start
- Mar 2014
- Primary completion
- 18 Aug 2014 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Late Preterm Infants (LPT) | – | Other: Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisition34 weeks and 0-6 days gestational age |
Who may qualify
- Ages
- 1 day to 4 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonatal intensive care unit Newborn nursery
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisition | Other | Late Preterm Infants (LPT) |
Primary outcome
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
3 secondary outcomes
Amplitude integrated electroencephalogram (aEEG)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Heart rate variability (HRV)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Respiratory variability (RV)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Results publication: PubMed 40538931Shah BA, Latremouille S, Chawla S, Keszler M, Tucker R, Laptook A, Sant'anna GM. Heart rate variability and amplitude-integrated electroencephalography measured shortly after birth and time to reach clinical milestones: a pilot study in late preterm infants. Front Pediatr. 2025 Jun 5;13:1579197. doi: 10.3389/fped.2025.1579197. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birju A Shah, MD, MPH principal investigator
Brown University - Women and Infants Hospital of Rhode Island
Abbot Laptook, MD principal investigator
Brown University - Women and Infants Hospital of Rhode Island
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurophysiologic Maturation, run by Brown University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of variance, R square (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02156817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.