Cerebral Function Monitoring in Premature Infants

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 may be useful in predicting neuromotor and neurocognitive deficits.
However, up to 30% of extremely low birth weight infants with normal ultrasounds have adverse
outcomes, and MRI is not feasible when an infant is critically ill. Amplitude-integrated
electroencephalogram (aEEG) is a non-invasive, bedside instrument which allows real-time
monitoring of brain function and may provide additional information for predicting outcomes
in extremely premature infants.

This observational study 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. Eligible infants will undergo an aEEG recording in 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.

The study tests the feasibility of enrolling subjects and obtaining the required aEEG
recordings. The information gathered will provide a framework for the design of a potential
prospective, observational, multi-center study for prediction of death or neurodevelopmental
impairment by 18-22 months of age.

Inclusion Criteria:

- 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:

- 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