RECRUITING

Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

Quick Facts

Study Start:2015-05
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02793999

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 2 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Therapeutic Hypothermia (TH) Group:
  2. 1. Undergo TH as part of their clinical management
  3. 2. Parents consent to multiple measures in the first week of life.
  4. 2. No Therapeutic Hypothermia (no-TH) Group:
  5. 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.
  6. 2. Parents consent to multiple measures in the first week of life.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Rutvi Vyas, MS
CONTACT
857-218-5445
rutvi.vyas@childrens.harvard.edu
Sarah Blackwell
CONTACT
857-218-5445
sarah.blackwell@childrens.harvard.edu

Principal Investigator

Patricia Ellen Grant, MD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-05
Study Completion Date2027-05

Study Record Updates

Study Start Date2015-05
Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

  • Hypoxic Ischemic Brain Injury
  • Neonatal Encephalopathy