Actively Recruiting
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
Led by Boston Children's Hospital · Updated on 2025-12-10
125
Participants Needed
3
Research Sites
678 weeks
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
B
Brigham and Women's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates must be older than 33 weeks gestational age
- For the Therapeutic Hypothermia (TH) group: undergoing TH as part of clinical care and parents consent to multiple measures in the first week of life
- For the No Therapeutic Hypothermia (no-TH) group: signs of neonatal encephalopathy such as seizures, abnormal consciousness, breathing difficulties, feeding problems, or abnormal tone/reflexes and parents consent to multiple measures in the first week of life
You will not qualify if you...
- Neonates born at or before 33 weeks gestational age or weighing less than 2.0 kg
- Presence of implanted devices or other devices that prevent MRI use, excluding participation in follow-up MRI session
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
Research Team
R
Rutvi Vyas, MS
CONTACT
S
Sarah Blackwell
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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