Cerebral Function Monitoring in Premature Infants

Completed

Conditions studied: Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Electroencephalography

In brief

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.

Key facts

Study ID

NCT00873847

Run by

NICHD Neonatal Research Network

People needed

102

Starts

2009-07-01

Expected to finish

2012-08-01

Last updated by the study team

2017-09-26

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Palo Alto, California, United States
• Emory University — Atlanta, Georgia, United States
• Wayne State University — Detroit, Michigan, United States
• RTI International — Durham, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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