Functional Imaging of Baby Brains (FIBB)

March 26, 2024 updated by: Hamilton Health Sciences Corporation

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L9G0C1
        • McMaster Childrens Hospital
        • Contact:
        • Sub-Investigator:
          • Gabriel Xiao, PhD
        • Sub-Investigator:
          • Qing Fang, PhD
        • Principal Investigator:
          • Lehana Thabane, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consent rate
Time Frame: 12 months
An eligible patient (parents or substitute decision makers) consents to the study
12 months
Rate of completion of study intervention
Time Frame: 12 months
An enrolled patient receives DOT measurements taken within 7 days of life
12 months
Rate of successful data acquisition
Time Frame: 12 months
An enrolled patient completes resting state DOT data acquisition within 45 mins without sedation
12 months
Rate of developmental follow up
Time Frame: 12 months
An enrolled patient is assessed for neurological outcome at the age of 6 months and 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting state connectivity measures
Time Frame: 12 months
Strength of network connectivity in pre-identified brain regions i.e somatosensory cortex and auditory cortex
12 months
First time-point developmental assessment
Time Frame: 6 months post menstrual age
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
Second time-point developmental assessment
Time Frame: 12 months post menstrual age
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIF-22535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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