Recruiting

MicroEEG

Sponsor:

Bio-Signal Group Corp.

Code:

NCT02436616

Conditions

Apnea

Bradycardia

Premature Birth

Seizures

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

microEEG

Study Details

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.

Conditions

Apnea

Bradycardia

Premature Birth

Seizures

Study ID

NCT02436616

Start date

Jan, 2013

Status verified date

Nov, 2014

Completion date

Jul, 2016

Anticipated

Primary completion date

Jun, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Any scalp skin lesions such as pustules, large abrasions The patient will be Withdrawn if

  • Informed consent is withdrawn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

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

EEG monitoring

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

Interventions

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.

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. ]

Central Contacts and Locations

Central contacts

Samah Abdel Baki, MD

3473460729sbaki@biosignalgroup.com

Zachary Ibrahim, MD

9172184700zachary.ibrahim@downstate.edu

Locations

State University of New York/Downstate Medical Center

Recruiting

Brooklyn, New York, United States, 11203

Contacts

Zachary Ibrahim, MD

718-613-8442zachary.Ibrahim@downstate.edu

Geetha Chari, MD

9177600714geetha.chari@downstate.edu

Brookdale University Hospital and Medical Center,

Recruiting

Brooklyn, New York, United States, 11212

Contacts

Roger Kim, MD

917-836-3613rkim@brookdale.edu

More Information

Sponsor

Bio-Signal Group Corp.

Last update posted

Feb 29, 2016

Last verified

Nov, 2014

Keywords

  • EEG
  • Preterm Infants
  • Neonate
  • wireless

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bio-Signal Group Corp. on 2016-02-29.