Cerebral Function Monitoring in Premature Infants

• ClinicalTrials.gov Identifier: NCT00873847
• Recruitment Status: Completed
• First Posted: April 2, 2009
• Last Update Posted: September 26, 2017
• Sponsor: NICHD Neonatal Research Network
• Collaborators: National Center for Research Resources (NCRR); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): NICHD Neonatal Research Network

Study Description

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.

Condition or disease
Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Electroencephalography

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 Design

• Study Type: Observational
• Actual Enrollment: 102 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cerebral Function Monitoring and Brain Injury in Preterm Infants: Correlation With Neuroimaging Abnormalities and Neurodevelopmental Impairment - a Pilot Study
• Study Start Date: July 2009
• Actual Primary Completion Date: June 2010
• Actual Study Completion Date: August 2012

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. First aEEG within 72 hours of age [ Time Frame: < 72 hours of age ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: up to 72 Hours (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

United States, California

Stanford University

Palo Alto, California, United States, 94304

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30303

United States, Michigan

Wayne State University

Detroit, Michigan, United States, 48201

United States, North Carolina

RTI International

Durham, North Carolina, United States, 27705

Duke University

Durham, North Carolina, United States, 27710

United States, Rhode Island

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States, 02905

United States, Texas

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States, 75235

University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Sponsors and Collaborators

NICHD Neonatal Research Network

National Center for Research Resources (NCRR)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Abbot R. Laptook, MD; Brown University, Women & Infants Hospital of Rhode Island
• Principal Investigator: Ricki F. Goldstein, MD; Duke University
• Principal Investigator: Barbara J. Stoll, MD; Emory University
• Principal Investigator: Abhik Das, PhD; RTI International
• Principal Investigator: Alexis Davis, MD; Stanford University
• Principal Investigator: Lina Chalak, MD; University of Texas, Southwestern Medical Center at Dallas
• Principal Investigator: Kathleen A. Kennedy, MD MPH; The University of Texas Health Science Center, Houston
• Principal Investigator: Seetha Shankaran, MD; Wayne State University

More Information

Additional Information:

NICHD Neonatal Research Network 

Publications of Results:

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.

• Responsible Party: NICHD Neonatal Research Network
• ClinicalTrials.gov Identifier: NCT00873847
• Other Study ID Numbers: NICHD-NRN-0042; U10HD021373 ( U.S. NIH Grant/Contract ); U10HD021385 ( U.S. NIH Grant/Contract ); U10HD027851 ( U.S. NIH Grant/Contract ); U10HD027880 ( U.S. NIH Grant/Contract ); U10HD027904 ( U.S. NIH Grant/Contract ); U10HD040492 ( U.S. NIH Grant/Contract ); U10HD040689 ( U.S. NIH Grant/Contract ); UL1RR025744 ( U.S. NIH Grant/Contract )
• First Posted: April 2, 2009
• Last Update Posted: September 26, 2017
• Last Verified: September 2017

Keywords provided by NICHD Neonatal Research Network:

NICHD Neonatal Research Network; Very Low Birth Weight (VLBW); Extremely Low Birth Weight (ELBW); Prematurity; Amplitude-integrated Electroencephalography (aEEG)

Additional relevant MeSH terms:

Premature Birth; Birth Weight; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Body Weight