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Cerebral Function Monitoring in Premature Infants

NCT00873847 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2017-09-26

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

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

    collaborator NIH

  • NICHD Neonatal Research Network

    lead NETWORK

Principal Investigators

  • Abbot R. Laptook, MD · Brown University, Women & Infants Hospital of Rhode Island

  • Ricki F. Goldstein, MD · Duke University

  • Barbara J. Stoll, MD · Emory University

  • Abhik Das, PhD · RTI International

  • Alexis Davis, MD · Stanford University

  • Lina Chalak, MD · University of Texas, Southwestern Medical Center at Dallas

  • Kathleen A. Kennedy, MD MPH · The University of Texas Health Science Center, Houston

  • Seetha Shankaran, MD · Wayne State University

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-06-30
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00873847 on ClinicalTrials.gov