microEEG for Neonatal Apnea, Bradycardia and Desaturation

NCT02436616 | Unknown DMC

• 1 other identifier: 307016-7
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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

Keywords

EEG; Preterm Infants; Neonate; wireless

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of seizure activity.

  From study enrollement to resolution of ABD events or 42 weeks corrected gesational age, whichever, comes first.

• Feasibility of microEEG recording in the NICU

  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

  From study enrollment (first 30 days of life) to resolution of ABD events or 42 weeks gesational age (whichever comes first)

Study Arms (1)

EEG monitoring

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

Device: microEEG

Interventions

microEEG DEVICE

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.

EEG monitoring

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature Infants born in hospital at the study centers

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Bio-Signal Group Corp.: lead
• State University of New York - Downstate Medical Center: collaborator
• Brookdale University Hospital Medical Center: collaborator

Study Sites (2)

State University of New York/Downstate Medical Center

Brooklyn, New York, 11203, United States

RECRUITING

Brookdale University Hospital and Medical Center,

Brooklyn, New York, 11212, United States

RECRUITING

Related Links

• Abstract from International Chil Neurology Congress

MeSH Terms

Conditions

Apnea; Bradycardia; Premature Birth; Seizures

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Zachary Ibrahim, MD

  State University of New York - Downstate Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samah Abdel Baki, MD

CONTACT

3473460729; sbaki@biosignalgroup.com

Zachary Ibrahim, MD

CONTACT

9172184700; zachary.ibrahim@downstate.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: May 7, 2015
• Study Start: January 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 29, 2016

Record last verified: 2014-11

Locations

US (2)