Status:
COMPLETED
Cerebral Function Monitoring in Premature Infants
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infant, Newborn
Infant, Low Birth Weight
Eligibility:
All Genders
Up to 72 years
Brief 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 betwee...
Detailed Description
Few techniques exist to permit early and accurate prognosis of brain injury in newborns. Cranial ultrasound and magnetic resonance imaging (MRI) have been used to detect structural abnormalities which...
Eligibility Criteria
Inclusion
- Inborn infants
- Between 401 grams and 1,000 grams inclusive birth weight OR between 23 0/7 and 28 6/7 weeks inclusive gestational age
- Decision to provide full intensive care support
- Less than 72 hours of age
Exclusion
- Non-intact skin at the central or parietal regions of scalp
- Presence of known or suspected congenital anomalies, including:
- Congenital central nervous system malformations
- Chromosomal anomalies or multiple congenital anomalies
- Complex congenital heart disease
- Inborn error of metabolism
- Acidosis (pH \< 6.8 for \> 2 hours)
- Persistent bradycardia \[HR \< 100 bpm\] associated with hypoxia for \> 2 hours
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00873847
Start Date
July 1 2009
End Date
August 1 2012
Last Update
September 26 2017
Active Locations (8)
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1
Stanford University
Palo Alto, California, United States, 94304
2
Emory University
Atlanta, Georgia, United States, 30303
3
Wayne State University
Detroit, Michigan, United States, 48201
4
RTI International
Durham, North Carolina, United States, 27705