Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
NCT02793999 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 125
Last updated 2025-12-10
Summary
The purpose of this study is to improve the ability of the investigators to monitor brain health in newborn babies at risk of brain injuries. The researchers will be using an investigational system of devices to non-invasively (that, is, without penetrating the skin), measure the amount of oxygen going to and being used by the brain. They will be taking some bedside research measurements during the babies' stay at the hospital. With these measurements, the intention is to study the role of oxygen in brain injury and test the efficacy of the research device and its potential as a permanent bedside diagnostic device.
Conditions
- Hypoxic Ischemic Brain Injury
- Neonatal Encephalopathy
Interventions
- DEVICE
-
Near-Infrared Spectroscopy (NIRS)
Sponsors & Collaborators
-
Brigham and Women's Hospital
collaborator OTHER -
Beth Israel Deaconess Medical Center
collaborator OTHER -
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH - lead OTHER
Principal Investigators
-
Patricia Ellen Grant, MD · Boston Children's Hospital
Eligibility
- Max Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2027-05-31
- Completion
- 2028-05-31
Countries
- United States
Study Locations
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