Neurophysiologic MaturationNEMONCT03722901
Neurophysiological Maturation Correlate With Clinical Milestones
An observational study of Neurophysiologic Maturation, run by Women and Infants Hospital of Rhode Island at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 4 days
- Conditions the study is for
- Neurophysiologic Maturation
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Aug 2013to 2 May 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 Up to 4 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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%)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurophysiologic Maturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Late preterm infants | 34 weeks and 0-6 days gestational age | |
| Moderate preterm infants | 32 weeks and 0-6 days gestational age | |
| Reference | Term infants 9m/39-40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variance between gestational age and time to reach clinical milestones for safe discharge among moderate and late preterm infants with and without neurophysiologic maturation
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
Measured: Hospital stay, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start5 Aug 2013
- Primary completion2 May 2017
- Study completion2 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- 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, Abbot Laptook, Women and Infants Hospital of Rhode Island
- Investigators
- Abbot Laptook, MD, Principal investigator, Women & Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722901
- Sponsor's protocol ID
- 792508-6
- Acronym
- NEMO
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiologic Maturation Index: The NEMO Project for Moderate and Late Preterm Infants
- ClinicalTrials.gov ID
- NCT03722901
- Acronym / sponsor ID
- NEMO / 792508-6
- Conditions
- Neurophysiologic Maturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Wayne State University
- Study start
- 5 Aug 2013 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 29 Oct 2018 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Late preterm infants | – | –34 weeks and 0-6 days gestational age |
| Moderate preterm infants | – | –32 weeks and 0-6 days gestational age |
| Reference | – | –Term infants 9m/39-40 |
Who may qualify
- Ages
- Up to 4 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates
Key inclusion criteria (7 listed)
- 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
- Gestational age of 39-40 weeks
- Care provided in a Newborn Nursery or rooming in with the mother
Key exclusion criteria (14 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.
Primary outcome
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
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 29 Oct 2018.
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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.
Abbot Laptook, MD principal investigator
Women & Infants Hospital
2 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 Women and Infants Hospital of Rhode Island at 2 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 7 inclusion and 14 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 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2018.