Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 2
SponsorBoston Children's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Undergo TH as part of their clinical management
Parents consent to multiple measures in the first week of life.
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.
Parents consent to multiple measures in the first week of life.
Disqualifiers
None
Trial population
Neonates must be \> 33 weeks gestational age (GA) and meet inclusion criteria for one of the two groups: 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Near-Infrared Spectroscopy (NIRS)
Device
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
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.
Time frame
early inpatient phase (0-2 months of age)Secondary outcomes
1
Perform NIRS, MRI and Neurodevelopmental testing (using Bayley Scales for Infant Development) between 2-12 months.
Explore correlations between all NIRS and MRI measures, and neurodevelopmental outcome at 2-12 months.
Time frame
up to 12 months of age2
Perform Neurodevelopmental testing at 16-24 months using Bayley Scales for Infant Development.
Explore correlations between all NIRS and MRI measures, and neurodevelopmental outcomes.
Time frame
up to 24 months of ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston Children's Hospital
Lead sponsor
Brigham and Women's Hospital
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov