RecruitingNCT05514665

Functional Imaging of Baby Brains

A Prospective Feasibility Study to Derive Novel Imaging Biomarker of Perinatal Brain Injury Based on Bedside Diffuse Optical Tomography in Neonates


Sponsor

Hamilton Health Sciences Corporation

Enrollment

25 participants

Start Date

Mar 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 1 DayMax Age: 15 Days

Inclusion Criteria3

  • 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 Criteria1

  • (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

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Interventions

DEVICEDiffuse 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.


Locations(1)

McMaster Children's Hospital

Hamilton, Ontario, Canada

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NCT05514665


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