Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

Recruiting now

Conditions studied: Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy

In brief

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.

Key facts

Study ID

NCT02793999

Run by

Boston Children's Hospital

People needed

125

Starts

2015-05-01

Expected to finish

2028-05-01

Last updated by the study team

2025-12-10

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neonates must be > 33 weeks gestational age (GA) and meet inclusion criteria for one of the two groups:
• 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.

You may not qualify if…

• 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 it is running

• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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