Cerebral Function Monitoring in Premature Infants

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00873847
First received: April 1, 2009
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • First aEEG within 72 hours of age [ Time Frame: < 72 hours of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time required by research personnel to conduct study activities [ Time Frame: Birth to 36 weeks post menstrual age ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: < 72 hours of age until 36 weeks post menstrual age ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Weekly aEEG until infant is 36 weeks post menstrual age [ Time Frame: < 72 hours of age until 36 weeks post menstrual age ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: July 2009
Study Completion Date: August 2012
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873847

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
Duke University
Durham, North Carolina, United States, 27710
RTI International
Durham, North Carolina, United States, 27705
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
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:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00873847     History of Changes
Other Study ID Numbers: NICHD-NRN-0042, U10HD021373, U10HD021385, U10HD027851, U10HD027880, U10HD027904, U10HD040492, U10HD040689, UL1RR025744
Study First Received: April 1, 2009
Last Updated: January 14, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
NICHD Neonatal Research Network
Very Low Birth Weight (VLBW)
Extremely Low Birth Weight (ELBW)
Prematurity
Amplitude-integrated Electroencephalography (aEEG)

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014