Monitoring brain health in newborns at risk of brain injuries
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
This study is testing a new device to monitor brain health in newborns at risk of brain injuries to see how oxygen levels affect their recovery during their hospital stay.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | N/A to 2 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT02793999 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the monitoring of brain health in newborns who are at risk for brain injuries due to hypoxic ischemic conditions. Researchers will utilize an innovative non-invasive device, Near-Infrared Spectroscopy (NIRS), to measure cerebral oxygen levels and metabolism in real-time during the infants' hospital stay. By comparing two groups of neonates—those receiving therapeutic hypothermia and those who are not—the study seeks to understand the role of oxygen in brain injury and evaluate the effectiveness of the NIRS device as a potential bedside diagnostic tool.
Who should consider this trial
Good fit: Ideal candidates include neonates over 33 weeks gestational age who show signs of neonatal encephalopathy and whose parents consent to multiple measurements.
Not a fit: Patients who are born at or below 33 weeks gestational age or weigh less than 2.0 kg may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of brain injuries in newborns, potentially reducing long-term disabilities.
How similar studies have performed: Other studies have shown promise in using NIRS for monitoring cerebral oxygenation, but this specific approach is innovative and not widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: Neonates must be \> 33 weeks gestational age (GA) and meet inclusion criteria for one of the two groups: 1. Therapeutic Hypothermia (TH) Group: 1. Undergo TH as part of their clinical management 2. Parents consent to multiple measures in the first week of life. 2. No Therapeutic Hypothermia (no-TH) Group: 1. 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. 2. Parents consent to multiple measures in the first week of life. Exclusion criteria: Exclusion criteria includes neonates born at GA ≤ 33 weeks or \< 2.0 kg, with implanted devices or other devices that preclude the use of MRI will be excluded from the follow up MRI session.
Where this trial is running
Boston, Massachusetts and 2 other locations
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Patricia Ellen Grant, MD — Boston Children's Hospital
- Study coordinator: Rutvi Vyas, MS
- Email: rutvi.vyas@childrens.harvard.edu
- Phone: 857-218-5445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.