Cerebral Function Monitoring in Premature Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT

Identifier Type: -

Identifier Source: org_study_id

Cerebral Function Monitoring in Premature Infants

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Center for Research Resources (NCRR)

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

NICHD Neonatal Research Network

Responsible Party

Principal Investigators

Abbot R. Laptook, MD

Ricki F. Goldstein, MD

Barbara J. Stoll, MD

Abhik Das, PhD

Alexis Davis, MD

Lina Chalak, MD

Kathleen A. Kennedy, MD MPH

Seetha Shankaran, MD

Locations

Stanford University

Emory University

Wayne State University

RTI International

Duke University

Brown University, Women & Infants Hospital of Rhode Island

University of Texas Southwestern Medical Center at Dallas

University of Texas Health Science Center at Houston

Countries

References

Related Links

Other Identifiers

U10HD021373

U10HD021385

U10HD027851

U10HD027880

U10HD027904

U10HD040492

U10HD040689

UL1RR025744

NICHD-NRN-0042