Hypoxia Ischemia, CerebralFIBBNCT05514665
Functional Imaging of Baby Brains
An observational study of Hypoxia Ischemia, Cerebral and Hypoxia-Ischemia, Brain, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 15 days
- Conditions the study is for
- Hypoxia Ischemia, Cerebral, Hypoxia-Ischemia, Brain, Hypoxia Neonatal
- What is being tested?
- Diffuse Optical Tomography
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2024to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 15 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario, L8N3Z5
Heather Johnson Clinical Research Coordinator, 9055212100, johnsh30@mcmaster.ca
Ipsita Goswami Principal Investigator, MD, 9055212100 ext. 72934, goswamii@mcmaster.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypoxia Ischemia, Cerebral, Hypoxia-Ischemia, Brain, Hypoxia Neonatal, Hypoxic-Ischemic Encephalopathy
- Being tested
- Diffuse Optical Tomography
- Keywords
- diffuse optical tomography, functional near-infrared spectroscopy, neuroimaging, functional connectivity, resting state networks
- Medical subject headings
- Hypoxia-Ischemia, Brain, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffuse Optical TomographyDevice
Neonates once hemodynamically stable will undergo diffuse optical tomography measurements of functional brain connectivity at the bedside within 3-7 days after birth.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Diffuse Optical Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate
An eligible patient (parents or substitute decision makers) consents to the study
Measured: 12 months
Rate of completion of study intervention
An enrolled patient receives DOT measurements taken within 7 days of life
Measured: 12 months
Rate of successful data acquisition
An enrolled patient completes resting state DOT data acquisition within 45 mins without sedation
Measured: 12 months
Rate of developmental follow up
An enrolled patient is assessed for neurological outcome at the age of 6 months and 12 months
Measured: 12 months
Secondary outcomes (3)
Resting state connectivity measures
Strength of network connectivity in pre-identified brain regions i.e somatosensory cortex and auditory cortex
Measured: 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.
Measured: 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
Measured: 12 months post menstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start15 Mar 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hypoxia Ischemia, CerebralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514665
- Sponsor's protocol ID
- NIF-22535
- Acronym
- FIBB
- Status last verified
- Mar 2024
- First submitted
- 18 Aug 2022
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Doria V, Beckmann CF, Arichi T, Merchant N, Groppo M, Turkheimer FE, Counsell SJ, Murgasova M, Aljabar P, Nunes RG, Larkman DJ, Rees G, Edwards AD. Emergence of resting state networks in the preterm human brain. Proc Natl Acad Sci U S A. 2010 Nov 16;107(46):20015-20. doi: 10.1073/pnas.1007921107. Epub 2010 Nov 1.
PubMed 21041625Gao W, Alcauter S, Elton A, Hernandez-Castillo CR, Smith JK, Ramirez J, Lin W. Functional Network Development During the First Year: Relative Sequence and Socioeconomic Correlations. Cereb Cortex. 2015 Sep;25(9):2919-28. doi: 10.1093/cercor/bhu088. Epub 2014 May 8.
PubMed 24812084Fransson P, Skiold B, Horsch S, Nordell A, Blennow M, Lagercrantz H, Aden U. Resting-state networks in the infant brain. Proc Natl Acad Sci U S A. 2007 Sep 25;104(39):15531-6. doi: 10.1073/pnas.0704380104. Epub 2007 Sep 18.
PubMed 17878310Gollenberg AL, Lynch CD, Jackson LW, McGuinness BM, Msall ME. Concurrent validity of the parent-completed Ages and Stages Questionnaires, 2nd Ed. with the Bayley Scales of Infant Development II in a low-risk sample. Child Care Health Dev. 2010 Jul;36(4):485-90. doi: 10.1111/j.1365-2214.2009.01041.x. Epub 2009 Dec 16.
PubMed 20030657Ferradal SL, Liao SM, Eggebrecht AT, Shimony JS, Inder TE, Culver JP, Smyser CD. Functional Imaging of the Developing Brain at the Bedside Using Diffuse Optical Tomography. Cereb Cortex. 2016 Apr;26(4):1558-68. doi: 10.1093/cercor/bhu320. Epub 2015 Jan 16.
PubMed 25595183Liao 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.
PubMed 20459255Niu H, Li Z, Liao X, Wang J, Zhao T, Shu N, Zhao X, He Y. Test-retest reliability of graph metrics in functional brain networks: a resting-state fNIRS study. PLoS One. 2013 Sep 9;8(9):e72425. doi: 10.1371/journal.pone.0072425. eCollection 2013.
PubMed 24039763Lee 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.
PubMed 28419082Smyser CD, Wheelock MD, Limbrick DD Jr, Neil JJ. Neonatal brain injury and aberrant connectivity. Neuroimage. 2019 Jan 15;185:609-623. doi: 10.1016/j.neuroimage.2018.07.057. Epub 2018 Jul 27.
PubMed 30059733Zhang X, Toronov V, Webb A. Simultaneous integrated diffuse optical tomography and functional magnetic resonance imaging of the human brain. Opt Express. 2005 Jul 11;13(14):5513-21. doi: 10.1364/opex.13.005513.
PubMed 19498547
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Study to Derive Novel Imaging Biomarker of Perinatal Brain Injury Based on Bedside Diffuse Optical Tomography in Neonates
- ClinicalTrials.gov ID
- NCT05514665
- Acronym / sponsor ID
- FIBB / NIF-22535
- Conditions
- Hypoxia Ischemia, Cerebral, Hypoxia-Ischemia, Brain, Hypoxia Neonatal, Hypoxic-Ischemic Encephalopathy
- Keywords
- diffuse optical tomography, functional near-infrared spectroscopy, neuroimaging, functional connectivity, resting state networks
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates with perinatal hypoxic-ischemic brain injury | – | Device: Diffuse Optical TomographyNeonates 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. |
Who may qualify
- Ages
- 1 day to 15 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffuse Optical TomographyNeonates once hemodynamically stable will undergo diffuse optical tomography measurements of functional brain connectivity at the bedside within 3-7 days after birth. | Device | Neonates with perinatal hypoxic-ischemic brain injury |
Primary outcome
Consent rate
Time frame: 12 months
An eligible patient (parents or substitute decision makers) consents to the study
Rate of completion of study intervention
Time frame: 12 months
An enrolled patient receives DOT measurements taken within 7 days of life
Rate of successful data acquisition
Time frame: 12 months
An enrolled patient completes resting state DOT data acquisition within 45 mins without sedation
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
3 secondary outcomes
Resting state connectivity measures
Time frame: 12 months
First time-point developmental assessment
Time frame: 6 months post menstrual age
Second time-point developmental assessment
Time frame: 12 months post menstrual age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Background: PubMed 21041625Doria V, Beckmann CF, Arichi T, Merchant N, Groppo M, Turkheimer FE, Counsell SJ, Murgasova M, Aljabar P, Nunes RG, Larkman DJ, Rees G, Edwards AD. Emergence of resting state networks in the preterm human brain. Proc Natl Acad Sci U S A. 2010 Nov 16;107(46):20015-20. doi: 10.1073/pnas.1007921107. Epub 2010 Nov 1.
- Background: PubMed 24812084Gao W, Alcauter S, Elton A, Hernandez-Castillo CR, Smith JK, Ramirez J, Lin W. Functional Network Development During the First Year: Relative Sequence and Socioeconomic Correlations. Cereb Cortex. 2015 Sep;25(9):2919-28. doi: 10.1093/cercor/bhu088. Epub 2014 May 8.
- Background: PubMed 17878310Fransson P, Skiold B, Horsch S, Nordell A, Blennow M, Lagercrantz H, Aden U. Resting-state networks in the infant brain. Proc Natl Acad Sci U S A. 2007 Sep 25;104(39):15531-6. doi: 10.1073/pnas.0704380104. Epub 2007 Sep 18.
- Background: PubMed 20030657Gollenberg AL, Lynch CD, Jackson LW, McGuinness BM, Msall ME. Concurrent validity of the parent-completed Ages and Stages Questionnaires, 2nd Ed. with the Bayley Scales of Infant Development II in a low-risk sample. Child Care Health Dev. 2010 Jul;36(4):485-90. doi: 10.1111/j.1365-2214.2009.01041.x. Epub 2009 Dec 16.
- Background: PubMed 25595183Ferradal SL, Liao SM, Eggebrecht AT, Shimony JS, Inder TE, Culver JP, Smyser CD. Functional Imaging of the Developing Brain at the Bedside Using Diffuse Optical Tomography. Cereb Cortex. 2016 Apr;26(4):1558-68. doi: 10.1093/cercor/bhu320. Epub 2015 Jan 16.
- Background: PubMed 20459255Liao 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.
- Background: PubMed 24039763Niu H, Li Z, Liao X, Wang J, Zhao T, Shu N, Zhao X, He Y. Test-retest reliability of graph metrics in functional brain networks: a resting-state fNIRS study. PLoS One. 2013 Sep 9;8(9):e72425. doi: 10.1371/journal.pone.0072425. eCollection 2013.
- Background: PubMed 28419082Lee 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.
- Background: PubMed 30059733Smyser CD, Wheelock MD, Limbrick DD Jr, Neil JJ. Neonatal brain injury and aberrant connectivity. Neuroimage. 2019 Jan 15;185:609-623. doi: 10.1016/j.neuroimage.2018.07.057. Epub 2018 Jul 27.
- Background: PubMed 19498547Zhang X, Toronov V, Webb A. Simultaneous integrated diffuse optical tomography and functional magnetic resonance imaging of the human brain. Opt Express. 2005 Jul 11;13(14):5513-21. doi: 10.1364/opex.13.005513.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia Ischemia, Cerebral and Hypoxia-Ischemia, Brain, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ipsita Goswami, MD, MSc (9055212100 ext. 72934, goswamii@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rate (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05514665, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.