Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

Recruiting

Conditions: Hypoxic Ischemic Brain Injury
Neonatal Encephalopathy

Registration Number: NCT02793999

Lead Sponsor: Boston Children's Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Perform NIRS, MRI and Neurodevelopmental testing (using Bayley Scales for Infant Development) between 2-12 months.;Perform Neurodevelopmental testing at 16-24 months using Bayley Scales for Infant Development.