ApneaNCT02436616
microEEG for Neonatal Apnea, Bradycardia and Desaturation
An observational study of Apnea and Bradycardia, run by Bio-Signal Group Corp. at 2 sites in United States.
Trial summary
The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively investigate the cerebral electrical activity of infants with Apnea, Bradycardia and Desaturation events. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Apnea, Bradycardia, Premature Birth
- What is being tested?
- microEEG
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2013to Jul 2016
- 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 30 days
- All sexes
- No healthy volunteers
- Child
Study population: Premature Infants born in hospital at the study centers
Who may be able to join
- gestational age (GA) 24-32 weeks
- postnatal ages 0-30 days. The patients will be recruited upon manifesting one of the following
- apneas (cessation of breathing > 10 seconds) x2 in a 12 hour span
- bradycardias (HR < 100/min) x2 in 12 hours
- oxygen desaturations (<80%) x 2 in 12 hours
- a single ABD event that does not resolve with stimulation or an increase in fractional oxygen delivery (FiO2).
Who cannot join
- major malformations
- The infant has exposed dermis on the scalp due to immaturity
- Any scalp skin lesions such as pustules, large abrasions The patient will be Withdrawn if
- Informed consent is withdrawn
- adverse events (i.e..scalp lesions) develop
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
State University of New York/Downstate Medical Center
Brooklyn, New York, 11203
Zachary Ibrahim, MD, 718-613-8442, zachary.Ibrahim@downstate.edu
Geetha Chari, MD, 9177600714, geetha.chari@downstate.edu
- Recruiting
Brookdale University Hospital and Medical Center,
Brooklyn, New York, 11212
Roger Kim, MD, 917-836-3613, rkim@brookdale.edu
About this study
Official title: Wireless Novel microEEG for Neonatal Apnea and Community Neurological Network
The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively investigate the cerebral electrical activity of infants with Apnea, Bradycardia and Desaturation events. This project will also assess the feasibility of using the microEEG device in the Neonatal Intensive Care Unit (NICU) setting and the feasibility of remote centralized interpretation in this setting.
Read the detailed description
Most preterm infants have episodes of apnea (cessation of breathing), bradycardia (low heart rate), and desaturations (low levels of oxygen in the blood) (ABD events). The resolution of ABD episodes depends to a large extent on the maturation of the central nervous system (CNS). The electroencephalogram (EEG) is a reliable and noninvasive tool for recording the electrical activity of the CNS. The relationship between ABD events and cerebral electrical activity has not been well investigated. The investigators seek to examine the relationship between EEG findings and the resolution of ABD events in the developing premature infant.
To investigate this relationship and obtain findings which are relevant to clinical care, a variety of obstacles need to be overcome. Among these obstacles is the high cost of standard EEG machines, inability of most standard machines to operate in electrically-noisy environments such as the NICU, and the absence of full-time coverage neurologists for prompt EEG interpretation. The investigators seek to determine the feasibility of obtaining an artifact-free EEG in the NICU with accurate detection of background rhythm abnormalities. The investigators will utilize an existing digital wireless telemetry unit, the "microEEG" for the NICU for this purpose. The microEEG device is specifically designed to overcome obstacles to standard EEG recording.
To address the shortage of trained pediatric neurophysiologists, the investigators will investigate the feasibility of a case management system for centralized EEG interpretation using off-site neurologists.
Finally, the investigators will examine the inter-rater reliability of EEG interpretation in the developing premature infant. This will allow the development of consensus guidelines for EEG interpretations.
- Conditions
- Apnea, Bradycardia, Premature Birth, Seizures
- Being tested
- microEEG
- Keywords
- EEG, Preterm Infants, Neonate, wireless
- Medical subject headings
- Apnea, Bradycardia, Premature Birth, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microEEGDevice
microEEG is a miniature, wireless, and battery-powered EEG device used to obtain EEG recording in challenging environment. All infants have an initial EEG at study enrollment. Follow up microEEGs will be performed at approximately 2-4 week intervals, depending on the Corrected Gestational Age (CGA).
If ABD events have not resolved at 34 weeks, an 8 hour recording will be performed prior to discharge or at 42 weeks CGA, whichever comes first. EEG will be assessed in 3 hour epochs. The EEG will be reviewed off line by two blinded neurologists and classified as normal or abnormal based on CGA and other findings. Follow up EEGs will be scored similarly, with emphasis on maturation.
| Study group | Role | What they receive |
|---|---|---|
| EEG monitoring | All subjects enrolled in this observational study will undergo EEG monitoring using the microEEG device. Receives: Device: microEEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between EEG background activity and resolution of Apnea, Bradycardia and Desaturation
Primary outcome measure is to assess the background EEG activity in infants with ABD events and determine the relationship between abnormal initial EEG background activity and the resolution of ABD events at 34 weeks Corrected Gestational Age
Measured: Initial 8-9 hours EEG will be done upon study enrollment in the first 30 days of life.
Secondary outcomes (3)
Rate of seizure activity.
All EEG recordings will be assessed by a pediatric neurophysiologist for seizure activity using standard clinical criteria. Based on their findings the rate of seizure will be determined.
Measured: From study enrollement to resolution of ABD events or 42 weeks corrected gesational age, whichever, comes first.
Feasibility of microEEG recording in the NICU
Assess the ability of neonatal staff to utilize the microEEG to obtain EEG in the NICU. This will be done by measuring the percentage of completed recordings that are interpretable by a pediatric neurophysiologist.
Measured: From study enrollment (first 30 days of life) to resolution of ABD events or 42 weeks gesational age (whichever comes first)
Interrater reliability of neonatal EEG interpretation
Assess the inter-rater reliability of neonatal EEG interpretations using data obtained in the course of the study.
Measured: From study enrollment (first 30 days of life) to resolution of ABD events or 42 weeks gesational age (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApneaStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio-Signal Group Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- State University of New York - Downstate Medical Center, Brookdale University Hospital Medical Center
- Responsible party
- Sponsor
- Investigators
- Zachary Ibrahim, MD, Principal investigator, State University of New York - Downstate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436616
- Sponsor's protocol ID
- 307016-7
- Status last verified
- Nov 2014
- First submitted
- 25 Nov 2014
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Novel microEEG for Neonatal Apnea and Community Neurological Network
- ClinicalTrials.gov ID
- NCT02436616
- Acronym / sponsor ID
- 307016-7
- Conditions
- Apnea, Bradycardia, Premature Birth, Seizures
- Keywords
- EEG, Preterm Infants, Neonate, wireless
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bio-Signal Group Corp.Industry (pharma, biotech, devices)
- Collaborators
- State University of New York - Downstate Medical Center, Brookdale University Hospital Medical Center
- Study start
- Jan 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 7 May 2015 (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.
The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively investigate the cerebral electrical activity of infants with Apnea, Bradycardia and Desaturation events. This project will also assess the feasibility of using the microEEG device in the Neonatal Intensive Care Unit (NICU) setting and the feasibility of remote centralized interpretation in this setting.
Detailed description
Most preterm infants have episodes of apnea (cessation of breathing), bradycardia (low heart rate), and desaturations (low levels of oxygen in the blood) (ABD events). The resolution of ABD episodes depends to a large extent on the maturation of the central nervous system (CNS). The electroencephalogram (EEG) is a reliable and noninvasive tool for recording the electrical activity of the CNS. The relationship between ABD events and cerebral electrical activity has not been well investigated. The investigators seek to examine the relationship between EEG findings and the resolution of ABD events in the developing premature infant.
To investigate this relationship and obtain findings which are relevant to clinical care, a variety of obstacles need to be overcome. Among these obstacles is the high cost of standard EEG machines, inability of most standard machines to operate in electrically-noisy environments such as the NICU, and the absence of full-time coverage neurologists for prompt EEG interpretation. The investigators seek to determine the feasibility of obtaining an artifact-free EEG in the NICU with accurate detection of background rhythm abnormalities. The investigators will utilize an existing digital wireless telemetry unit, the "microEEG" for the NICU for this purpose. The microEEG device is specifically designed to overcome obstacles to standard EEG recording.
To address the shortage of trained pediatric neurophysiologists, the investigators will investigate the feasibility of a case management system for centralized EEG interpretation using off-site neurologists.
Finally, the investigators will examine the inter-rater reliability of EEG interpretation in the developing premature infant. This will allow the development of consensus guidelines for EEG interpretations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EEG monitoring | – | Device: microEEGAll subjects enrolled in this observational study will undergo EEG monitoring using the microEEG device. |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature Infants born in hospital at the study centers
Key inclusion criteria (6 listed)
- gestational age (GA) 24-32 weeks
- postnatal ages 0-30 days. The patients will be recruited upon manifesting one of the following
Key exclusion criteria (5 listed)
- major malformations
- The infant has exposed dermis on the scalp due to immaturity
- Any scalp skin lesions such as pustules, large abrasions The patient will be Withdrawn if
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 |
|---|---|---|
| microEEGmicroEEG is a miniature, wireless, and battery-powered EEG device used to obtain EEG recording in challenging environment. All infants have an initial EEG at study enrollment. Follow up microEEGs will be performed at approximately 2-4 week intervals, depending on the Corrected Gestational Age (CGA). If ABD events have not resolved at 34 weeks, an 8 hour recording will be performed prior to discharge or at 42 weeks CGA, whichever comes first. EEG will be assessed in 3 hour epochs. The EEG will be reviewed off line by two blinded neurologists and classified as normal or abnormal based on CGA and other findings. Follow up EEGs will be scored similarly, with emphasis on maturation. | Device | EEG monitoring |
Primary outcome
Correlation between EEG background activity and resolution of Apnea, Bradycardia and Desaturation
Time frame: Initial 8-9 hours EEG will be done upon study enrollment in the first 30 days of life.
Primary outcome measure is to assess the background EEG activity in infants with ABD events and determine the relationship between abnormal initial EEG background activity and the resolution of ABD events at 34 weeks Corrected Gestational Age
3 secondary outcomes
Rate of seizure activity.
Time frame: From study enrollement to resolution of ABD events or 42 weeks corrected gesational age, whichever, comes first.
Feasibility of microEEG recording in the NICU
Time frame: From study enrollment (first 30 days of life) to resolution of ABD events or 42 weeks gesational age (whichever comes first)
Interrater reliability of neonatal EEG interpretation
Time frame: From study enrollment (first 30 days of life) to resolution of ABD events or 42 weeks gesational age (whichever comes first)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Abstract from International Chil Neurology CongressLink provided by the sponsor.
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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.
Zachary Ibrahim, MD principal investigator
State University of New York - Downstate Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea and Bradycardia, run by Bio-Signal Group Corp. at 2 sites in United States.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Feb 2016. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samah Abdel Baki, MD (3473460729, sbaki@biosignalgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between EEG background activity and resolution of Apnea, Bradycardia and Desaturation (time frame: Initial 8-9 hours EEG will be done upon study enrollment in the first 30 days of life.). 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 Feb 2016.