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Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

Recruitingn/aAges any - 2 YearsAllBoston Children's Hospital
NCT02793999 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Near-Infrared Spectroscopy (NIRS)
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Where

3 sites
Boston Children's Hospital
Boston, United States
Brigham and Women's Hospital
Boston, United States
Beth Israel Deaconess Medical Center
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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