Clinical trial NCT00873847: Cerebral Function Monitoring in Premature Infants
Official title: Cerebral Function Monitoring and Brain Injury in Preterm Infants: Correlation With Neuroimaging Abnormalities and Neurodevelopmental Impairment - a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
Electroencephalography
Keywords: NICHD Neonatal Research Network
Very Low Birth Weight (VLBW)
Extremely Low Birth Weight (ELBW)
Prematurity
Amplitude-integrated Electroencephalography (aEEG)
Lead sponsor: NICHD Neonatal Research Network
Sponsor class: NETWORK
Collaborators: name: National Center for Research Resources (NCRR)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2009-04-02
Enrollment: 102
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born at NRN centers and admitted to the NICU that are between 401 grams and 1,000 grams OR between 23 0/7 and 28 6/7 weeks gestational age. Infants must be enrolled by the time they are 72 hours old.

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: First aEEG within 72 hours of age
timeFrame: < 72 hours of age
Secondary outcomes:
measure: Time required by research personnel to conduct study activities
timeFrame: Birth to 36 weeks post menstrual age
measure: Serious adverse events
timeFrame: < 72 hours of age until 36 weeks post menstrual age
measure: Agreement between aEEG recordings and clinical events including: seizures, cardiopulmonary resuscitation, surfactant administration, suctioning, and intubation
timeFrame: < 72 hours of age until 36 weeks post menstrual age
measure: Weekly aEEG until infant is 36 weeks post menstrual age
timeFrame: < 72 hours of age until 36 weeks post menstrual age
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Durham
country: United States
facility: RTI International
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Providence
country: United States
facility: Brown University, Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: Brown University, Women & Infants Hospital of Rhode Island
name: Abbot R. Laptook, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Ricki F. Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Barbara J. Stoll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: Abhik Das, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Alexis Davis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas, Southwestern Medical Center at Dallas
name: Lina Chalak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Kathleen A. Kennedy, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Seetha Shankaran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis AS, Gantz MG, Do B, Shankaran S, Hamrick SE, Kennedy KA, Tyson JE, Chalak LF, Laptook AR, Goldstein RF, Hintz SR, Das A, Higgins RD, Ball MB, Hale EC, Van Meurs KP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Serial aEEG recordings in a cohort of extremely preterm infants: feasibility and safety. J Perinatol. 2015 May;35(5):373-8. doi: 10.1038/jp.2014.217. Epub 2014 Dec 4.