At a glance
ClinicalIndex Comparison RecordN/ACompleted· 102 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cerebral Function Monitoring and Brain Injury in Preterm Infants: Correlation With Neuroimaging Abnormalities and Neurodevelopmental Impairment - a Pilot Study
In Brief
An observational study for Infant, Newborn and 4 related conditions. Completed, enrolled 102 participants across 8 sites.
Detailed Summary
This observational study tests the feasibility of enrolling subjects and obtaining an amplitude-integrated electroencephalogram (aEEG) within the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and weekly thereafter up to 36 weeks post-menstrual age. It will enroll 85-100 infants between 401-1,000 grams birth weight OR between 23 0/7 and 28 6/7 weeks gestational age born at the 7 participating NICHD Neonatal Research Network sites.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Electroencephalography
CountriesUnited States
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2009
Enrollment StartJul 2009
Primary CompletionJun 2010
Study CompletionAug 2012
TodayJul 2026
First PostedApr 2, 2009
Enrollment StartJul 1, 2009
Primary CompletionJun 1, 2010
Study CompletionAug 1, 2012
TodayJul 1, 2026
Enrollment to primary: 11 monthsPosted 17.2 years ago