Using advanced imaging to assess brain function in newborns with brain injury
A Prospective Feasibility Study to Derive Novel Imaging Biomarker of Perinatal Brain Injury Based on Bedside Diffuse Optical Tomography in Neonates
This study is testing a new imaging tool to see if it can help doctors predict how well newborns with brain injuries will develop, compared to traditional MRI scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 1 Day to 15 Days |
| Sex | All |
| Sponsor | Hamilton Health Sciences Corporation Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT05514665 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility of using diffuse optical tomography (DOT) as a bedside neuroimaging tool to predict neurodevelopmental outcomes in neonates diagnosed with hypoxic-ischemic encephalopathy. By comparing DOT with conventional MRI techniques, the study seeks to enhance the prognostic capabilities for identifying infants at risk of developing cognitive and motor disabilities due to perinatal brain injury. The research focuses on understanding functional connectivity in the brain during the neonatal period, which is crucial for early intervention strategies. The study is being conducted at McMaster Children's Hospital, where newborns with specific eligibility criteria will be monitored and assessed.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns admitted to the neonatal intensive care unit with a diagnosis of hypoxic-ischemic encephalopathy, who are at least 35 weeks gestational age and weigh more than 1.8 kg.
Not a fit: Patients with congenital malformations, chromosomal anomalies, or other significant neonatal conditions unrelated to hypoxic-ischemic encephalopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early identification of infants at risk for neurodevelopmental disabilities, allowing for timely interventions.
How similar studies have performed: While the use of diffuse optical tomography has shown promise in small studies, this approach is relatively novel in the neonatal clinical setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newborns admitted to the McMaster Children's Hospital Neonatal Intensive Care Unit with the diagnosis of hypoxic-ischemic encephalopathy will be considered for this study * Gestational age of 35 weeks or greater * Birth weight more than 1.8 Kg Exclusion Criteria: (i) suspected or confirmed congenital malformations, (ii) chromosomal anomalies, (iii) inborn errors of metabolism, (iv) congenital infections, (v) neonatal encephalopathy other than HIE, (vi) baby requires respiratory support in the form of CPAP, Mechanical ventilation, high flow nasal cannula and (vii) scalp injury or non-intact skin surface in the scalp
Where this trial is running
Hamilton, Ontario
- McMaster Children's Hospital — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Ipsita Goswami, MD, MSc
- Email: goswamii@mcmaster.ca
- Phone: 9055212100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.