An observational study in Hypoxia Ischemia, Cerebral, Hypoxia-Ischemia, Brain and Hypoxia Neonatal, sponsored by Hamilton Health Sciences Corporation. Recruiting at 1 site in Canada. Open to participants aged 1 Day to 15 Days. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Hamilton Health Sciences Corporation · Observational
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.
Perinatal hypoxic-ischemic brain injury is a major cause of childhood disabilities including cerebral palsy, developmental delay, attention deficits, behavioral concerns, and learning disabilities. Accurate prediction of neurologic deficits in the neonatal period is difficult, especially the ability to predict later cognitive impairment and socio-emotional challenges. Many of these disabilities are manifested at school age when the child is beyond the critical time window of early brain development. Prognostic tools that help to identify neonates most at risk of developing neuro-deficits after perinatal asphyxia are needed and would enable targeted early intervention in infancy, when the developing brain is most amenable to positive changes and improve neurologic outcome. Currently, structural changes observed in MRI brain images are used to predict outcome. However, this modality does not provide information on brain function, nor is it a good prognostic marker of future neurocognitive outcome. Functional MRI (fMRI) is time-consuming and not commonly a part of clinical assessment of the neonates. Diffuse Optical Tomography (DOT) using near-infrared light has been applied in research settings to map the functional connections between key brain regions. This technology, although reported to be safe and reliable in small studies, has not been widely used in the neonatal clinical setting. This approach is based on the synchronous, spontaneous fluctuations of cerebral blood flow in different regions of the brain that are functionally, yet not necessarily anatomically connected. DOT combines the portability and cap-based scanning of EEG with spatial resolution high enough to create detailed cortical maps of the neonatal brain. Compared to MRI and fMRI brain imaging, DOT is portable, light weight, has high body motion tolerance, does not produce noise and does not require infant sedation. It has the potential to be a powerful bedside non-invasive clinical neuroimaging tool. Currently, the predictive accuracy of DOT based neonatal brain connectivity measures in prognosticating early childhood is unknown. This study aims to assess the feasibility of the processes that are key to the success of a large-scale prospective study aimed at investigating the prognostic value of bedside DOT derived biomarker in neonatal brain after perinatal hypoxic-ischemic brain injury.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 95 are open to participants now.
This study's planned enrollment of 25 is below the median of 100 across 92 observational studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Hamilton Health Sciences Corporation is the lead sponsor of 242 studies on the registry; 38 are open to participants now.
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A cohort of neonates admitted with clinical history suggestive of perinatal hypoxic-ischemic encephalopathy will be enrolled to the study, irrespective of whether they are considered eligible or ineligible for therapeutic hypothermia. The intervention (DOT measurement) will be conducted after therapeutic hypothermia is completed and neonate is considered hemodynamically stable to tolerate the procedure.
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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
Neonates who are admitted to the Level III Neonatal Intensive Care Unit with a diagnosis of hypoxic ischemic encephalopathy will undergo diffuse optical tomography measurements prior to discharge from Neonatal Intensive Care Unit . Their developmental assessment will be performed at 6 months and 12 months postmenstrual age.
Device: Diffuse Optical Tomography
Neonates once hemodynamically stable will undergo diffuse optical tomography measurements of functional brain connectivity at the bedside within 3-7 days after birth.
Consent rate
An eligible patient (parents or substitute decision makers) consents to the study
Time frame: 12 months
Rate of completion of study intervention
An enrolled patient receives DOT measurements taken within 7 days of life
Time frame: 12 months
Rate of successful data acquisition
An enrolled patient completes resting state DOT data acquisition within 45 mins without sedation
Time frame: 12 months
Rate of developmental follow up
An enrolled patient is assessed for neurological outcome at the age of 6 months and 12 months
Time frame: 12 months
Resting state connectivity measures
Strength of network connectivity in pre-identified brain regions i.e somatosensory cortex and auditory cortex
Time frame: 12 months
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.
Time frame: 6 months post menstrual age
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
Time frame: 12 months post menstrual age
Plan to share: Undecided
Started Mar 2024 (actual). Primary completion is estimated for Apr 2026, 24 months after the start.
Of 47 non-industry observational studies under Hypoxia-Ischemia, Brain, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20. This study's planned 24 months is below that.
Counting every sponsor, half of 51 studies reached it within 43 months; a quarter within 20.
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