Clinical trial NCT02436616: microEEG for Neonatal Apnea, Bradycardia and Desaturation
Official title: Wireless Novel microEEG for Neonatal Apnea and Community Neurological Network
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Apnea
Bradycardia
Premature Birth
Seizures
Keywords: EEG
Preterm Infants
Neonate
wireless
Lead sponsor: Bio-Signal Group Corp.
Sponsor class: INDUSTRY
Collaborators: name: State University of New York - Downstate Medical Center
name: Brookdale University Hospital Medical Center
First posted: 2015-05-07
Enrollment: 50
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature Infants born in hospital at the study centers

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. gestational age (GA) 24-32 weeks
2. 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).

Exclusion Criteria:

1. major malformations
2. The infant has exposed dermis on the scalp due to immaturity
3. 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

Primary outcomes:
measure: Correlation between EEG background activity and resolution of Apnea, Bradycardia and Desaturation
timeFrame: Initial 8-9 hours EEG will be done upon study enrollment in the first 30 days of life.
Secondary outcomes:
measure: Rate of seizure activity.
timeFrame: From study enrollement to resolution of ABD events or 42 weeks corrected gesational age, whichever, comes first.
measure: Feasibility of microEEG recording in the NICU
timeFrame: From study enrollment (first 30 days of life) to resolution of ABD events or 42 weeks gesational age (whichever comes first)
measure: Interrater reliability of neonatal EEG interpretation
timeFrame: From study enrollment (first 30 days of life) to resolution of ABD events or 42 weeks gesational age (whichever comes first)
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: State University of New York/Downstate Medical Center
state: New York
city: Brooklyn
country: United States
facility: Brookdale University Hospital and Medical Center,
state: New York
Study officials:
affiliation: State University of New York - Downstate Medical Center
name: Zachary Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
References: