Monitoring brain health in newborns at risk of brain injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance the monitoring of brain health in newborns who are at risk for brain injuries due to hypoxic ischemic conditions. Researchers will utilize an innovative non-invasive device, Near-Infrared Spectroscopy (NIRS), to measure cerebral oxygen levels and metabolism in real-time during the infants' hospital stay. By comparing two groups of neonates—those receiving therapeutic hypothermia and those who are not—the study seeks to understand the role of oxygen in brain injury and evaluate the effectiveness of the NIRS device as a potential bedside diagnostic tool.

Why it matters

Who can join: the full rules

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.

Where it's running

• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Not yet recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Not yet recruiting

Study contacts

• Principal investigator: Patricia Ellen Grant, MD — Boston Children's Hospital
• Study coordinator: Rutvi Vyas, MS
• Email: rutvi.vyas@childrens.harvard.edu
• Phone: 857-218-5445

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.