Cerebral Function Monitoring in Premature Infants

Completed

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

• Registration Number: NCT00873847
• Lead Sponsor: NICHD Neonatal Research Network

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.

Study Timeline

• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Study Start: 2009-07
• Primary Completion: 2010-06
• Study Completion: 2012-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-22
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First aEEG within 72 hours of age	< 72 hours of age

Secondary Outcome Measures

Name	Time	Method
Weekly aEEG until infant is 36 weeks post menstrual age	< 72 hours of age until 36 weeks post menstrual age
Time required by research personnel to conduct study activities	Birth to 36 weeks post menstrual age
Serious adverse events	< 72 hours of age until 36 weeks post menstrual age
Agreement between aEEG recordings and clinical events including: seizures, cardiopulmonary resuscitation, surfactant administration, suctioning, and intubation	< 72 hours of age until 36 weeks post menstrual age

Trial Locations

Locations (8)

Stanford University; 🇺🇸 Palo Alto, California, United States

RTI International; 🇺🇸 Durham, North Carolina, United States

Brown University, Women & Infants Hospital of Rhode Island; 🇺🇸 Providence, Rhode Island, United States

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Texas Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

Duke University; 🇺🇸 Durham, North Carolina, United States