Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

NCT02793999 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

  • Hypoxic Ischemic Brain Injury
  • Neonatal Encephalopathy

Interventions

DEVICE

Near-Infrared Spectroscopy (NIRS)

Sponsors & Collaborators

Principal Investigators

  • Patricia Ellen Grant, MD · Boston Children's Hospital

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2027-05-31
Completion
2028-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02793999 on ClinicalTrials.gov