Cerebral Function Monitoring in Premature Infants

Infant, Premature Clinical Trial

Official title:

Cerebral Function Monitoring and Brain Injury in Preterm Infants: Correlation With Neuroimaging Abnormalities and Neurodevelopmental Impairment - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873847
• Other study ID #: NICHD-NRN-0042
• Secondary ID: U10HD021373U10HD
• Status: Completed
• Phase: N/A
• First received: April 1, 2009
• Last updated: September 22, 2017
• Start date: July 2009
• Est. completion date: August 2012

Study information

• Verified date: September 2017
• Source: NICHD Neonatal Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 2012
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

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

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
NICHD Neonatal Research Network	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Neon — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First aEEG within 72 hours of age		< 72 hours of age
Secondary	Time required by research personnel to conduct study activities		Birth to 36 weeks post menstrual age
Secondary	Serious adverse events		< 72 hours of age until 36 weeks post menstrual age
Secondary	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
Secondary	Weekly aEEG until infant is 36 weeks post menstrual age		< 72 hours of age until 36 weeks post menstrual age

External Links

•   NICHD Neonatal Research Network