Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT02793999
Status
Recruiting
Apply to this trial

Conditions

  • Hypoxic Ischemic Brain Injury
  • Neonatal Encephalopathy

Eligibility Criteria

Sex
ALL
Age
N/A - 2 Years
Healthy Volunteers
Not accepted

Interventions

  • Near-Infrared Spectroscopy (NIRS) — DEVICE

Study Details

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.

Key Dates

Start date
May 31, 2015
Status verified
Dec 2025
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
125 participants (estimated)

Primary Outcome Measure

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. [ Time Frame: early inpatient phase (0-2 months of age) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Rutvi Vyas, MS
[email protected]
857-218-5445
Francesca Yi
[email protected]
857-218-5445
Jonathan Litt, MD (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalBostonMassachusetts02115-
Brigham and Women's HospitalBostonMassachusetts02115
Rutvi Vyas, MS
[email protected]
857-218-5445
Francesca Yi
[email protected]
857-218-5445
Terrie Inder, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Beth Israel Deaconess Medical Center· Boston, MABoston Children's Hospital· Boston, MABrigham and Women's Hospital· Boston, MA

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