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NCT02793999 · ClinicalTrials.gov registry record
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
A clinical trial of Neonatal Encephalopathy and Hypoxic-Ischemic Brain Injury, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- 125
- Enrollment target
- 3
- Study locations
NCT02793999: Recruiting study of Neonatal Encephalopathy and Hypoxic-Ischemic Brain Injury, sponsored by Boston Children's Hospital.
NCT02793999 is a study of Neonatal Encephalopathy and Hypoxic-Ischemic Brain Injury that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 125 participants, roughly in line with the 116-participant average among 6 other Neonatal Encephalopathy trials with a reported enrollment target. The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02793999, a study of Neonatal Encephalopathy and Hypoxic-Ischemic Brain Injury, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- 125 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Near-Infrared Spectroscopy (NIRS)
Study Locations (3)
Massachusetts
- Boston Children's Hospital - Boston
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2015-05 |
| Est. Completion | 2028-05 |
What NCT02793999 shows while recruiting
NCT02793999 is an observational study that tracks outcomes without assigning an intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 116-participant average among 6 other Neonatal Encephalopathy trials with a reported enrollment target.
The record links to 2 conditions, with Neonatal Encephalopathy appearing as the primary indexed condition, and to 1 intervention - of which Near-Infrared Spectroscopy (NIRS) is the first listed.
NCT02793999 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02793999 about?
NCT02793999 is a clinical study titled "Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia". 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 go...
What is the current status of trial NCT02793999?
This trial is currently recruiting. The enrollment target is 125 participants. The study started on 2015-05. Estimated completion is 2028-05.
What conditions does trial NCT02793999 study?
This clinical trial studies the following conditions: Neonatal Encephalopathy, Hypoxic-Ischemic Brain Injury.
What interventions are being tested in trial NCT02793999?
The interventions under investigation include: Near-Infrared Spectroscopy (NIRS) (DEVICE).
Who is sponsoring clinical trial NCT02793999?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02793999 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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