Recruiting

NIRS

Sponsor:

Boston Children's Hospital

Code:

NCT02793999

Conditions

Hypoxic Ischemic Brain Injury

Neonatal Encephalopathy

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Near-Infrared Spectroscopy (NIRS)

Study Details

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

Study ID

NCT02793999

Start date

May, 2015

Status verified date

Dec, 2025

Completion date

May, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Inclusion criteria:

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.

Exclusion criteria:

Exclusion criteria includes neonates born at GA ≤ 33 weeks or < 2.0 kg, with implanted devices or other devices that preclude the use of MRI will be excluded from the follow up MRI session.

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Interventions

Near-Infrared Spectroscopy (NIRS)

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 and Locations

Central contacts

Rutvi Vyas, MS

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

Sarah Blackwell

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

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Boston Children's Hospital

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-12-10.