Cerebral Function Monitoring in Premature Infants

September 22, 2017 updated by: NICHD Neonatal Research Network

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Palo Alto, California, United States, 94304
    - Stanford University
- Georgia
  - Atlanta, Georgia, United States, 30303
    - Emory University
- Michigan
  - Detroit, Michigan, United States, 48201
    - Wayne State University
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Duke University
  - Durham, North Carolina, United States, 27705
    - RTI International
- Rhode Island
  - Providence, Rhode Island, United States, 02905
    - Brown University, Women & Infants Hospital of Rhode Island
- Texas
  - Dallas, Texas, United States, 75235
    - University Of Texas Southwestern Medical Center At Dallas
  - Houston, Texas, United States, 77030
    - University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
First aEEG within 72 hours of age Time Frame: < 72 hours of age	< 72 hours of age

Secondary Outcome Measures

Outcome Measure	Time Frame
Time required by research personnel to conduct study activities Time Frame: Birth to 36 weeks post menstrual age	Birth to 36 weeks post menstrual age
Serious adverse events Time Frame: < 72 hours of age until 36 weeks post menstrual age	< 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 Time Frame: < 72 hours of age until 36 weeks post menstrual age	< 72 hours of age until 36 weeks post menstrual age
Weekly aEEG until infant is 36 weeks post menstrual age Time Frame: < 72 hours of age until 36 weeks post menstrual age	< 72 hours of age until 36 weeks post menstrual age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NICHD Neonatal Research Network

Collaborators

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

National Center for Research Resources (NCRR)

Investigators

Principal Investigator: Ricki F. Goldstein, MD, Duke University
Principal Investigator: Alexis Davis, MD, Stanford University
Principal Investigator: Lina Chalak, MD, University of Texas, Southwestern Medical Center at Dallas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

NICHD Neonatal Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

April 1, 2009

First Submitted That Met QC Criteria