Hypoxic-Ischemic Encephalopathy Clinical Trial
— FIBBOfficial title:
A Prospective Feasibility Study to Derive Novel Imaging Biomarker of Perinatal Brain Injury Based on Bedside Diffuse Optical Tomography in Neonates
NCT number | NCT05514665 |
Other study ID # | NIF-22535 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2024 |
Est. completion date | April 1, 2026 |
Infants are at risk of developing motor and cognitive neurodevelopmental disabilities as a sequelae to hypoxic-ischemic brain injury during the perinatal period. It is an ongoing challenge to predict the severity and extent of future developmental impairment during the neonatal period. This study will help test the feasibility of conducting a large-scale study that evaluates the role of diffuse optical tomography as a bedside neuroimaging tool in complementing the prognostic value of conventional and diffusion weighted MRI for predicting neurodevelopmental outcome in neonates with perinatal hypoxic-ischemic brain injury.
Status | Not yet recruiting |
Enrollment | 25 |
Est. completion date | April 1, 2026 |
Est. primary completion date | April 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 7 Days |
Eligibility | 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: - suspected or confirmed congenital brain malformations - chromosomal anomalies - inborn errors of metabolism - congenital TORCH infections - neonatal encephalopathy other than hypoxic-ischemic encephalopathy - confirmed meningitis |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster Childrens Hospital | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation | McMaster University |
Canada,
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Lee CW, Cooper RJ, Austin T. Diffuse optical tomography to investigate the newborn brain. Pediatr Res. 2017 Sep;82(3):376-386. doi: 10.1038/pr.2017.107. Epub 2017 May 31. — View Citation
Liao SM, Gregg NM, White BR, Zeff BW, Bjerkaas KA, Inder TE, Culver JP. Neonatal hemodynamic response to visual cortex activity: high-density near-infrared spectroscopy study. J Biomed Opt. 2010 Mar-Apr;15(2):026010. doi: 10.1117/1.3369809. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Consent rate | An eligible patient (parents or substitute decision makers) consents to the study | 12 months | |
Primary | Rate of completion of study intervention | An enrolled patient receives DOT measurements taken within 7 days of life | 12 months | |
Primary | Rate of successful data acquisition | An enrolled patient completes resting state DOT data acquisition within 45 mins without sedation | 12 months | |
Primary | Rate of developmental follow up | An enrolled patient is assessed for neurological outcome at the age of 6 months and 12 months | 12 months | |
Secondary | Resting state connectivity measures | Strength of network connectivity in pre-identified brain regions i.e somatosensory cortex and auditory cortex | 12 months | |
Secondary | First time-point developmental assessment | Assessed by parent-filled questionnaire using Ages and Stages Questionnaire-3 rd edition. Total score in each domain (Cognitive, Gross motor, Fine motor, Problem solving, Personal social) ranges from 0-60. Higher score is better. | 6 months post menstrual age | |
Secondary | Second time-point developmental assessment | Assessed by parent-filled questionnaire using Ages and Stages Questionnaire-3 rd edition. Total score in each domain (Cognitive, Gross motor, Fine motor, Problem solving, Personal social) ranges from 0-60. Higher score is better | 12 months post menstrual age |
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