microEEG for Neonatal Apnea, Bradycardia and Desaturation

Premature Birth Clinical Trial

Official title:

Wireless Novel microEEG for Neonatal Apnea and Community Neurological Network

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02436616
• Other study ID #: 307016-7
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2014
• Last updated: February 26, 2016
• Start date: January 2013
• Est. completion date: July 2016

Study information

• Verified date: November 2014
• Source: Bio-Signal Group Corp.
• Contact: Samah Abdel Baki, MD
• Phone: 3473460729
• Email: sbaki[@]biosignalgroup.com
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Bradycardia
• Premature Birth
• Seizures

Intervention

Device:
• microEEG
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.

Locations

Country	Name	City	State
United States	Brookdale University Hospital and Medical Center,	Brooklyn	New York
United States	State University of New York/Downstate Medical Center	Brooklyn	New York

Sponsors (3)

Lead Sponsor	Collaborator
Bio-Signal Group Corp.	Brookdale University Hospital Medical Center, State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Initial 8-9 hours EEG will be done upon study enrollment in the first 30 days of life.	No
Secondary	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.	From study enrollement to resolution of ABD events or 42 weeks corrected gesational age, whichever, comes first.	No
Secondary	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.	From study enrollment (first 30 days of life) to resolution of ABD events or 42 weeks gesational age (whichever comes first)	No
Secondary	Interrater reliability of neonatal EEG interpretation	Assess the inter-rater reliability of neonatal EEG interpretations using data obtained in the course of the study.	From study enrollment (first 30 days of life) to resolution of ABD events or 42 weeks gesational age (whichever comes first)	No

External Links

•   Abstract from International Chil Neurology Congress
•   Research Portfolio Online Reporting Tools Grant Description