Intraventricular Hemorrhage of Newborn Grade 2PIONIRSNCT05708105
Prediction of Intraventricular Hemorrhage Using Echocardiography and Near Infrared Spectroscopy
An observational study of Intraventricular Hemorrhage of Newborn Grade 2 and Intraventricular Hemorrhage of Newborn Grade 3, run by Mount Sinai Hospital, Canada at 4 sites in Canada.
Trial summary
Moderate-severe intraventricular hemorrhage (msIVH, Grades II-IV) is a significant neurological complication among extremely low gestational age neonates (ELGANs, <=27+6 weeks) and is associated with long-term neuro-disabilities. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intraventricular Hemorrhage of Newborn Grade 2, Intraventricular Hemorrhage of Newborn Grade 3, Intraventricular Haemorrhage Grade IV
- What is being tested?
- Cerebral near-infrared spectroscopy, Functional echocardiography and Head Ultrasound
- How many people
- 380 participants
- Where
- 4 sitesCanada
- Study dates
- 22 Apr 2024to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Preterm infants at tertiary NICU admitted to one of four study NICUs: * Mount Sinai Hospital, Toronto (ON) * The Children's Hospital at London Health Sciences Center, London (ON) * Foothills Medical Centre, Calgary (AB) * Royal Alexandra Hospital, Edmonton (AB)
Who may be able to join
- Preterm infants born <=27+6 weeks gestational age
Who cannot join
- Known genetic or congenital anomalies that are likely to affect cardiac or cerebral oxygenation measures
- Palliative care plan prior to or immediately following delivery
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Not yet recruiting
Foothillls Medical Centre
Calgary, Alberta
Lara Leijser
- Not yet recruiting
Royal Alexandra Hospital
Edmonton, Alberta
Abbas Hyderi
- Not yet recruiting
London Health Sciences Centre
London, Ontario
Soume Bhattacharya
- Recruiting
Mount Sinai Hospital
Toronto, Ontario
Thaiani Wulff, thaiani.wulff@sinaihealth.ca
Phoebe Thum, MSc, phoebe.thum@sinaihealth.ca
About this study
Moderate-severe intraventricular hemorrhage (msIVH, Grades II-IV) is a significant neurological complication among extremely low gestational age neonates (ELGANs, <=27+6 weeks) and is associated with long-term neuro-disabilities. In Canada, msIVH affects ~25-30% of the 1300 ELGANs born annually, with little change in incidence over last decade. Typically, it occurs between days 2-7 of age, providing a finite window of opportunity. Instituting therapies at the population level, however, exposes many low-risk infants to side effects, adversely affecting risk-benefit profile and requiring large sample sizes in trials. A targeted preventative approach, though ideal, is currently challenged by our inability to reliably identify at-risk ELGANs early after birth. Near-infrared spectroscopy (NIRS) has emerged as a promising non-invasive bedside neuromonitoring tool. Pilot studies using NIRS, including ours, found lower cerebral saturations (CrSO2) and greater periods of altered cerebral autoregulation in infants who later developed msIVH. However, a systematic planned investigation is needed to establish the predictive characteristics of NIRS-derived markers, using clinically translatable methods (cumulative burden over time-period vs. single time-point values) and identify their relative performance at different time-points during transition. Further, incorporating echocardiographic (ECHO) hemodynamic markers, known to be associated with msIVH, may allow for the establishment of robust multi-model prediction models and the gain of mechanistic hemodynamic insights to inform future management. Hence, our objective is to investigate the utility of multi-modal assessment using NIRS and ECHO for early identification of ELGANs at risk of msIVH, and generate clinically applicable predictive model(s).
Read the detailed description
The overall objective is to conduct a large, adequately powered prospective cohort study to investigate the utility of combined hemodynamic assessment using NIRS and ECHO for early identification of ELGANs at risk of developing moderate-severe IVH, and to establish clinically translatable prediction models.
The specific primary aim is to examine the discriminating characteristics of NIRS-derived parameters (CrSO2 and cerebral oxygenation index [COIx, values >0.5 indicate altered cerebral autoregulation]) at 12, 18, 24, 30, 36, 42 and 48 hours of age, individually and in combination, for identifying ELGANs who subsequently develop moderate-severe IVH. The postnatal age where NIRS may best identify at-risk ELGANs is unknown and identifying these infants early within 48 hours of age may maximize its impact for employing neuroprotective strategies.
The secondary aims are:
- To examine if adding ECHO parameters of systemic blood flow (left ventricular output [LVO], superior vena cava [SVC] flow and PDA size) and patient demographics can improve the discriminating characteristics of NIRS and generate relevant clinical prediction models.
- To gain mechanistic insights into pathophysiology of moderate-severe IVH, by examining associations between significant abnormalities on NIRS, as identified and ECHO markers which may impact cerebral perfusion and oxygen delivery (PDA and its size, LVO, right ventricular output and left ventricular ejection fraction).
This will be novel information as potential mechanisms governing low CrSO2 or altered autoregulation in ELGANs are not known and can potentially inform future clinical preventative strategies and help design interventional trials.
- Conditions
- Intraventricular Hemorrhage of Newborn Grade 2, Intraventricular Hemorrhage of Newborn Grade 3, Intraventricular Haemorrhage Grade IV
- Being tested
- Cerebral near-infrared spectroscopy, Functional echocardiography, Head Ultrasound
- Keywords
- Near-infrared spectroscopy, Echocardiography, Head ultrasound, Preterm neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral near-infrared spectroscopyDiagnostic test
Also called NIRS
Continuous cerebral NIRS will be monitored using the INVOS 5100C or 7100 Cerebral Oximeter (Medtronic, Minneapolis, MN, USA), initiated as early as feasible after birth or postnatal consent and continued until 48 hours of age. Neonatal sensors applied over a light-permeable barrier will be placed on the right or left side of forehead, like the methods used in our pilot study and in line with our clinical protocol. The continuous parameters recorded for this study using cerebral NIRS will include CrSO2 and COIx.
Functional echocardiographyDiagnostic test
Also called Echo
The first echocardiogram will be completed as soon as possible after consent and < 24 hours of age in all cases. This will be to capture markers of early low systemic blood flow and document patent ductus arteriosus and its size, as known to be associated with IVH.
The second scan will be performed at the end of the monitoring period, between 48-60 hours of age. This scan is planned to record the change in LVO from baseline (re-perfusion), which has been postulated to relate to development of IVH.
Head UltrasoundDiagnostic test
Also called HUS
HUS will be paired with both echocardiograms. The first HUS will document baseline IVH status (paired with the first ECHO). The final HUS will be performed between days 4-7 of age, as per the standard clinical practice by site radiology service and will be used to confirm the final IVH status.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraventricular hemorrhage (IVH) Status
IVH will be classified using Volpe's classification which is also the clinical standard for IVH classification (Grade I: Blood in germinal matrix with or without IVH less than 10% of ventricular space; Grade II: IVH occupying 10-50% of ventricular space on parasagittal view; Grade III: IVH occupying >50% of ventricle with or without ventricular echo-densities; Grade IV: periventricular hemorrhagic infarction).
Measured: Day 4-7 clinical head ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start22 Apr 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraventricular Hemorrhage of Newborn Grade 2Studies 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
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre, Foothills Medical Centre, Royal Alexandra Hospital
- Responsible party
- Sponsor
- Investigators
- Poorva Deshpande, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708105
- Sponsor's protocol ID
- 486734
- Acronym
- PIONIRS
- Status last verified
- Mar 2025
- First submitted
- 23 Jan 2023
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Intraventricular Hemorrhage Using Echocardiography and Near Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT05708105
- Acronym / sponsor ID
- PIONIRS / 486734
- Conditions
- Intraventricular Hemorrhage of Newborn Grade 2, Intraventricular Hemorrhage of Newborn Grade 3, Intraventricular Haemorrhage Grade IV
- Keywords
- Near-infrared spectroscopy, Echocardiography, Head ultrasound, Preterm neonates
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- London Health Sciences Centre, Foothills Medical Centre, Royal Alexandra Hospital
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 1 Feb 2023 (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.
Moderate-severe intraventricular hemorrhage (msIVH, Grades II-IV) is a significant neurological complication among extremely low gestational age neonates (ELGANs, <=27+6 weeks) and is associated with long-term neuro-disabilities. In Canada, msIVH affects ~25-30% of the 1300 ELGANs born annually, with little change in incidence over last decade. Typically, it occurs between days 2-7 of age, providing a finite window of opportunity. Instituting therapies at the population level, however, exposes many low-risk infants to side effects, adversely affecting risk-benefit profile and requiring large sample sizes in trials. A targeted preventative approach, though ideal, is currently challenged by our inability to reliably identify at-risk ELGANs early after birth. Near-infrared spectroscopy (NIRS) has emerged as a promising non-invasive bedside neuromonitoring tool. Pilot studies using NIRS, including ours, found lower cerebral saturations (CrSO2) and greater periods of altered cerebral autoregulation in infants who later developed msIVH. However, a systematic planned investigation is needed to establish the predictive characteristics of NIRS-derived markers, using clinically translatable methods (cumulative burden over time-period vs. single time-point values) and identify their relative performance at different time-points during transition. Further, incorporating echocardiographic (ECHO) hemodynamic markers, known to be associated with msIVH, may allow for the establishment of robust multi-model prediction models and the gain of mechanistic hemodynamic insights to inform future management. Hence, our objective is to investigate the utility of multi-modal assessment using NIRS and ECHO for early identification of ELGANs at risk of msIVH, and generate clinically applicable predictive model(s).
Detailed description
The overall objective is to conduct a large, adequately powered prospective cohort study to investigate the utility of combined hemodynamic assessment using NIRS and ECHO for early identification of ELGANs at risk of developing moderate-severe IVH, and to establish clinically translatable prediction models.
The specific primary aim is to examine the discriminating characteristics of NIRS-derived parameters (CrSO2 and cerebral oxygenation index [COIx, values >0.5 indicate altered cerebral autoregulation]) at 12, 18, 24, 30, 36, 42 and 48 hours of age, individually and in combination, for identifying ELGANs who subsequently develop moderate-severe IVH. The postnatal age where NIRS may best identify at-risk ELGANs is unknown and identifying these infants early within 48 hours of age may maximize its impact for employing neuroprotective strategies.
The secondary aims are:
- To examine if adding ECHO parameters of systemic blood flow (left ventricular output [LVO], superior vena cava [SVC] flow and PDA size) and patient demographics can improve the discriminating characteristics of NIRS and generate relevant clinical prediction models.
- To gain mechanistic insights into pathophysiology of moderate-severe IVH, by examining associations between significant abnormalities on NIRS, as identified and ECHO markers which may impact cerebral perfusion and oxygen delivery (PDA and its size, LVO, right ventricular output and left ventricular ejection fraction).
This will be novel information as potential mechanisms governing low CrSO2 or altered autoregulation in ELGANs are not known and can potentially inform future clinical preventative strategies and help design interventional trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preterm infants at tertiary NICU admitted to one of four study NICUs: * Mount Sinai Hospital, Toronto (ON) * The Children's Hospital at London Health Sciences Center, London (ON) * Foothills Medical Centre, Calgary (AB) * Royal Alexandra Hospital, Edmonton (AB)
Key inclusion criteria (1 listed)
- Preterm infants born <=27+6 weeks gestational age
Key exclusion criteria (2 listed)
- Known genetic or congenital anomalies that are likely to affect cardiac or cerebral oxygenation measures
- Palliative care plan prior to or immediately following delivery
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 |
|---|---|---|
| Cerebral near-infrared spectroscopyAlso: NIRSContinuous cerebral NIRS will be monitored using the INVOS 5100C or 7100 Cerebral Oximeter (Medtronic, Minneapolis, MN, USA), initiated as early as feasible after birth or postnatal consent and continued until 48 hours of age. Neonatal sensors applied over a light-permeable barrier will be placed on the right or left side of forehead, like the methods used in our pilot study and in line with our clinical protocol. The continuous parameters recorded for this study using cerebral NIRS will include CrSO2 and COIx. | Diagnostic test | – |
| Functional echocardiographyAlso: EchoThe first echocardiogram will be completed as soon as possible after consent and < 24 hours of age in all cases. This will be to capture markers of early low systemic blood flow and document patent ductus arteriosus and its size, as known to be associated with IVH. The second scan will be performed at the end of the monitoring period, between 48-60 hours of age. This scan is planned to record the change in LVO from baseline (re-perfusion), which has been postulated to relate to development of IVH. | Diagnostic test | – |
| Head UltrasoundAlso: HUSHUS will be paired with both echocardiograms. The first HUS will document baseline IVH status (paired with the first ECHO). The final HUS will be performed between days 4-7 of age, as per the standard clinical practice by site radiology service and will be used to confirm the final IVH status. | Diagnostic test | – |
Primary outcome
Intraventricular hemorrhage (IVH) Status
Time frame: Day 4-7 clinical head ultrasound
IVH will be classified using Volpe's classification which is also the clinical standard for IVH classification (Grade I: Blood in germinal matrix with or without IVH less than 10% of ventricular space; Grade II: IVH occupying 10-50% of ventricular space on parasagittal view; Grade III: IVH occupying >50% of ventricle with or without ventricular echo-densities; Grade IV: periventricular hemorrhagic infarction).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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.
Poorva Deshpande principal investigator
MOUNT SINAI HOSPITAL
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraventricular Hemorrhage of Newborn Grade 2 and Intraventricular Hemorrhage of Newborn Grade 3, run by Mount Sinai Hospital, Canada at 4 sites 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Poorva Deshpande (4165864800 ext. 7213, poorva.deshpande@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraventricular hemorrhage (IVH) Status (time frame: Day 4-7 clinical head ultrasound). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2025.