Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 2
Healthy Volunteers: f
View:

∙ Neonates must be \> 33 weeks gestational age (GA) and meet inclusion criteria for one of the two groups:

• Therapeutic Hypothermia (TH) Group:

‣ Undergo TH as part of their clinical management

⁃ Parents consent to multiple measures in the first week of life.

• No Therapeutic Hypothermia (no-TH) Group:

‣ 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.

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
NOT_YET_RECRUITING
Boston
Boston Children's Hospital
RECRUITING
Boston
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Contact Information
Primary
Rutvi Vyas, MS
rutvi.vyas@childrens.harvard.edu
857-218-5445
Backup
Sarah Blackwell
sarah.blackwell@childrens.harvard.edu
857-218-5445
Time Frame
Start Date: 2015-05
Estimated Completion Date: 2028-05
Participants
Target number of participants: 125
Related Therapeutic Areas
Sponsors
Collaborators: Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov