Recruiting

Observational Study

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT05514665

Conditions

Hypoxia Ischemia, Cerebral

Hypoxia-Ischemia, Brain

Hypoxia Neonatal

Hypoxic-Ischemic Encephalopathy

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Diffuse Optical Tomography

Study Details

Brief 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.

Conditions

Hypoxia Ischemia, Cerebral

Hypoxia-Ischemia, Brain

Hypoxia Neonatal

Hypoxic-Ischemic Encephalopathy

Study ID

NCT05514665

Start date

Mar 15, 2024

Status verified date

Mar, 2024

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Neonates with perinatal hypoxic-ischemic brain injury

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.

Interventions

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.

Primary outcome measure

  • Consent rate [ Time Frame: 12 months ]
  • Rate of completion of study intervention [ Time Frame: 12 months ]
  • Rate of successful data acquisition [ Time Frame: 12 months ]
  • Rate of developmental follow up [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Ipsita Goswami, MD, MSc

9055212100goswamii@mcmaster.ca

Gabriel Xiao, PhD

9055259140xiao8@mcmaster.ca

Locations

McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8N3Z5

Contacts

Heather Johnson Clinical Research Coordinator

9055212100johnsh30@mcmaster.ca

Ipsita Goswami Principal Investigator, MD

9055212100goswamii@mcmaster.ca

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Oct 23, 2024

Last verified

Mar, 2024

Keywords

  • diffuse optical tomography
  • functional near-infrared spectroscopy
  • neuroimaging
  • functional connectivity
  • resting state networks

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2024-10-23.