microEEG for Neonatal Apnea, Bradycardia and Desaturation

Status unconfirmed

Conditions studied: Apnea, Bradycardia, Premature Birth, Seizures

In brief

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.

Key facts

Study ID

NCT02436616

Run by

Bio-Signal Group Corp.

People needed

50

Starts

2013-01-01

Expected to finish

2016-07-01

Last updated by the study team

2016-02-29

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

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• Any scalp skin lesions such as pustules, large abrasions The patient will be Withdrawn if
• Informed consent is withdrawn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

Where it is running

• State University of New York/Downstate Medical Center — Brooklyn, New York, United States (enrolling)
• Brookdale University Hospital and Medical Center, — Brooklyn, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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