Monitoring Brain Health in Newborns at Risk for Brain Injury

This study is looking at ways to better monitor the brain health of newborn babies who are at risk for brain injuries, specifically Hypoxic Ischemic Brain Injury (brain injury due to lack of oxygen) and Neonatal Encephalopathy (a type of brain dysfunction in newborns). Researchers are using a new device called Near-Infrared Spectroscopy (NIRS) to measure how much oxygen is going to and being used by the baby's brain. This device does not go into the skin. The goal is to see if this new NIRS technology can help understand the role of oxygen in brain injury and if it could become a standard tool for monitoring babies at the bedside. You might be able to join if your baby is over 33 weeks gestational age and is either receiving therapeutic hypothermia (cooling treatment for brain injury) or is in a group not receiving this treatment. The study aims to enroll 125 participants, but its current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will be watching and collecting information without giving new treatments. It plans to include 125 participants.
What's involved
Parents will need to agree to multiple measurements being taken during the baby's first week of life while they are in the hospital.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken during the early inpatient phase, up to 2 months of age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02793999

Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

Recruiting
Not specifiedUp to 2Observational
Boston Children's Hospital
~125 participants
Updated 2025-12-10 on ClinicalTrials.gov
What's tested:Near-Infrared Spectroscopy (NIRS)

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compare metrics such as hemoglobin oxygen saturation and cerebral metabolic rate of oxygen consumption as obtained from novel NIRS technology in neonates at risk for brain injury to normal controls.
Measured over early inpatient phase (0-2 months of age)
Hypoxic Ischemic Brain Injury
Neonatal Encephalopathy
3 sites across 1 states
Massachusetts3
  • Patricia Ellen Grant, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

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  • Compare metrics such as hemoglobin oxygen saturation and cerebral metabolic rate of oxygen consumption as obtained from novel NIRS technology in neonates at risk for brain injury to normal controls.early inpatient phase (0-2 months of age)

    The infants undergoing treatment with therapeutic hypothermia (TH) and those who are identified with neonatal brain injury but are not candidates for TH will be compared. Both groups will also be compared to normal controls.