Cerebral Function Monitoring in Premature Infants

N

NICHD Neonatal Research Network

Status

Completed

Conditions

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

Study type

Observational

Funder types

NETWORK
NIH

Identifiers

NCT00873847
NICHD-NRN-0042
U10HD021373 (U.S. NIH Grant/Contract)
UL1RR025744 (U.S. NIH Grant/Contract)
U10HD040492 (U.S. NIH Grant/Contract)
U10HD027851 (U.S. NIH Grant/Contract)
U10HD040689 (U.S. NIH Grant/Contract)
U10HD021385 (U.S. NIH Grant/Contract)
U10HD027904 (U.S. NIH Grant/Contract)
U10HD027880 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

102 patients

Sex

All

Ages

Under 72 hours old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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