Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

Launched by BOSTON CHILDREN'S HOSPITAL · Jun 3, 2016

Keywords

ClinConnect Summary

This clinical trial is studying how to better monitor the brain health of newborn babies who might be at risk for brain injuries, particularly those with conditions like hypoxic ischemic brain injury and neonatal encephalopathy. Researchers will use a special device that gently measures the amount of oxygen in the brain without needing to penetrate the skin. By taking these measurements during the babies' hospital stay, the team aims to learn more about how oxygen affects brain injury and to see if this device could be used regularly at the bedside to help doctors make better decisions for these vulnerable infants.

To be eligible for this study, babies need to be born after 33 weeks of pregnancy and show certain signs of potential brain injury. There are two main groups in the study: one group will receive a treatment called therapeutic hypothermia, which is used to help protect the brain, while the other group will not receive this treatment but will still show signs of brain injury. Parents who participate will need to give consent for their babies to undergo several monitoring tests during the first week of life. This research could lead to improved ways of caring for newborns at risk for brain injury, helping doctors better understand how to protect these little ones.

Gender

ALL

Eligibility criteria

• 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.