Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns

Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00516334

Acronym

BrainZ

Enrollment

100

Registered

2007-08-15

Start date

2006-05-31

Completion date

2013-05-31

Last updated

2012-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury, Cerebral Palsy, Seizures

Keywords

brain, electroencephalography, premature infant, neurodevelopment

Brief summary

This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.

Detailed description

Patient enrollment and electroencephalographic (EEG) and clinical data collection stopped May 2009. Data analysis is ongoing, and results have been described (O'Reilly D, Navakatikyan MA, Filip M, Greene D, Van Marter LJ. Peak to Peak Amplitude in Neonatal Brain Monitoring of Premature Infants. Clin Neurophysiol 2012 May 16), via publication in a peer-reviewed journal. Another manuscript has been completed and is undergoing revision for resubmission. We anticipate several additional articles will be completed from the data collected during this study. There is no relationship between industry and no current funding for this study. We maintain institutional review board approval due to ongoing data analysis.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 36 Months

Healthy volunteers

Inclusion criteria

* Infants inborn below 28 weeks gestation

Exclusion criteria

* At birth, deemed not likely to survive 7 days or more * Major intracranial congenital anomaly

Countries

United States

Outcome results