RecruitingNCT02793999

Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia


Sponsor

Boston Children's Hospital

Enrollment

125 participants

Start Date

May 1, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

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

Max Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This study uses innovative near-infrared spectroscopy (NIRS) brain monitoring technology in newborns who have experienced birth-related brain injury (hypoxic-ischemic encephalopathy or HIE). Researchers want to see if this new monitoring approach can help optimize cooling therapy (therapeutic hypothermia), which is used to protect the brain after birth injury. You may be eligible if: - Your newborn was born at more than 33 weeks gestational age - Your newborn is either: (1) receiving therapeutic hypothermia (cooling treatment) as clinical management, OR (2) showing signs of neurological problems such as seizures, altered consciousness, breathing difficulties, feeding problems, abnormal tone, or abnormal reflexes - Parents are willing to consent to monitoring in the first week of life You may NOT be eligible if: - Your newborn was born at 33 weeks or earlier (premature) - Your newborn weighs less than 2.0 kg at birth - Your newborn has an implanted device or other condition that prevents MRI scanning Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENear-Infrared Spectroscopy (NIRS)

Locations(3)

Boston Children's Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT02793999


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