microEEG for Neonatal Apnea, Bradycardia and Desaturation

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.

Study Overview

• Status: Unknown
• Conditions: Apnea; Premature Birth; Bradycardia; Seizures
• Intervention / Treatment: Device: microEEG

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Samah Abdel Baki, MD; Phone Number: 3473460729; Email: sbaki@biosignalgroup.com
• Study Contact Backup: Name: Zachary Ibrahim, MD; Phone Number: 9172184700; Email: zachary.ibrahim@downstate.edu

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11203
      • Recruiting
      • State University of New York/Downstate Medical Center
      • Contact: Zachary Ibrahim, MD; Phone Number: 718-613-8442; Email: zachary.Ibrahim@downstate.edu
      • Contact: Geetha Chari, MD; Phone Number: 9177600714; Email: geetha.chari@downstate.edu
    • Brooklyn, New York, United States, 11212
      • Recruiting
      • Brookdale University Hospital and Medical Center,
      • Contact: Roger Kim, MD; Phone Number: 917-836-3613; Email: rkim@brookdale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Premature Infants born in hospital at the study centers

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

EEG monitoring; All subjects enrolled in this observational study will undergo EEG monitoring using the microEEG device.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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)
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)

Collaborators and Investigators

• Sponsor: Bio-Signal Group Corp.
• Collaborators: State University of New York - Downstate Medical Center; Brookdale University Hospital Medical Center
• Investigators: Principal Investigator: Zachary Ibrahim, MD, State University of New York - Downstate Medical Center

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (Estimate): May 7, 2015

Study Record Updates

• Last Update Posted (Estimate): February 29, 2016
• Last Update Submitted That Met QC Criteria: February 26, 2016
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: EEG; Neonate; Preterm Infants; wireless
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Signs and Symptoms, Respiratory; Arrhythmias, Cardiac; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Apnea; Premature Birth; Bradycardia; Seizures
• Other Study ID Numbers: 307016-7