Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 2
SponsorBoston Children's Hospital
About this trial
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 criteria
Qualifiers
Undergo TH as part of their clinical management
Parents consent to multiple measures in the first week of life.
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Near-Infrared Spectroscopy (NIRS)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Boston Children's Hospital
Lead sponsor
Brigham and Women's Hospital
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov