Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
Boston Children's Hospital
125 participants
May 1, 2015
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Therapeutic Hypothermia (TH) Group:
- Undergo TH as part of their clinical management
- Parents consent to multiple measures in the first week of life.
- No Therapeutic Hypothermia (no-TH) Group:
- Signs will be defined broadly as any one of the following which can be considered evidence of NE caused by HIE or other etiologies: i) Seizures alone or ii) any of the following: abnormal consciousness, difficulty maintaining respiration, difficulty feeding (presumed central origin), abnormal tone or reflexes.
- Parents consent to multiple measures in the first week of life.
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Interventions
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT02793999