Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

Description

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

Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy

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Study Overview

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Study Details

Study overview

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.

Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

Condition
Hypoxic Ischemic Brain Injury
Intervention / Treatment

-

Contacts and Locations

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.

Ages Eligible for Study

to 2 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Children's Hospital,

Patricia Ellen Grant, MD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

2027-05