Cerebral Function Monitoring in Premature Infants

Trial ID or NCT#

NCT00873847

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Cerebral Function Monitoring and Brain Injury in Preterm Infants: Correlation With Neuroimaging Abnormalities and Neurodevelopmental Impairment - a Pilot Study

Eligibility Criteria

Ages Eligible for Study: Younger than 72 Hours
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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 Criteria:
  1. - 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
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Investigator(s)

Alexis Davis

View on ClinicalTrials.gov