Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

NCT02793999 | Recruiting

• 2 other identifiers: P00012473R01HD076258-02
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hypoxic Ischemic Brain Injury; Neonatal Encephalopathy

Outcome Measures

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.

  early inpatient phase (0-2 months of age)

Secondary Outcomes (2)

• Perform NIRS, MRI and Neurodevelopmental testing (using Bayley Scales for Infant Development) between 2-12 months.

  up to 12 months of age

• Perform Neurodevelopmental testing at 16-24 months using Bayley Scales for Infant Development.

  up to 24 months of age

Interventions

Near-Infrared Spectroscopy (NIRS) DEVICE

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• 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

Study Sites (3)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Patricia Ellen Grant, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rutvi Vyas, MS

CONTACT

857-218-5445; rutvi.vyas@childrens.harvard.edu

Sarah Blackwell

CONTACT

857-218-5445; sarah.blackwell@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: June 8, 2016
• Study Start: May 1, 2015
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)