Prediction of Intraventricular Hemorrhage Using Echocardiography and Near Infrared Spectroscopy

NCT05708105 | Recruiting

• 1 other identifier: 486734
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 4

Brief 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. 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).

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 4-7 clinical head ultrasound

Interventions

Cerebral near-infrared spectroscopy DIAGNOSTIC_TEST

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.

Also known as: NIRS

Functional echocardiography DIAGNOSTIC_TEST

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.

Also known as: Echo

Head Ultrasound DIAGNOSTIC_TEST

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.

Also known as: HUS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• Preterm infants born \<=27+6 weeks gestational age

You may not qualify if:

• Known genetic or congenital anomalies that are likely to affect cardiac or cerebral oxygenation measures
• Palliative care plan prior to or immediately following delivery

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• London Health Sciences Centre: collaborator
• Foothills Medical Centre: collaborator
• Royal Alexandra Hospital: collaborator

Study Sites (4)

Foothillls Medical Centre

Calgary, Alberta, Canada

NOT YET RECRUITING

Royal Alexandra Hospital

Edmonton, Alberta, Canada

NOT YET RECRUITING

London Health Sciences Centre

London, Ontario, Canada

NOT YET RECRUITING

Mount Sinai Hospital

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Interventions

Caves

Intervention Hierarchy (Ancestors)

Geological Phenomena; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Poorva Deshpande

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Poorva Deshpande

CONTACT

4165864800; poorva.deshpande@sinaihealth.ca

Laura Thomas, MSc

CONTACT

4165864800; laura.thomas@sinaihealth.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: April 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)