Predicting brain bleeding in premature infants using echocardiography and near-infrared spectroscopy
Official title: Prediction of Intraventricular Hemorrhage Using Echocardiography and Near Infrared Spectroscopy
Run by Mount Sinai Hospital, Canada · NCT05708105 · Data updated 2026-11-12
This study is trying to see if using special imaging techniques can help doctors find premature babies at risk of serious brain bleeding early on, so they can provide better care.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 380 (estimated) |
| Sponsor | Mount Sinai Hospital, Canada Academic / other |
| Locations | 4 sites (Calgary, Alberta and 3 other locations) |
| Status | Recruiting |
| Started | April 22, 2024 |
| Main results expected | June 1, 2026 |
| Study ends | November 1, 2027 |
| Registry record updated | March 24, 2025 |
| Trial ID | NCT05708105 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are preterm infants born at or before 27 weeks and 6 days of gestational age.
✕Probably not a fit
Patients with known genetic or congenital anomalies affecting cardiac or cerebral oxygenation, or those under a palliative care plan, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to identify extremely low gestational age neonates (ELGANs) at risk of developing moderate-severe intraventricular hemorrhage (IVH) by utilizing a combination of near-infrared spectroscopy (NIRS) and echocardiography (ECHO). The study will assess NIRS-derived parameters and ECHO markers over the first 48 hours of life to develop predictive models for early identification of at-risk infants. By focusing on this critical early window, the study seeks to enhance the implementation of neuroprotective strategies and improve outcomes for these vulnerable patients.
Why it matters
Potential benefit: If successful, this study could lead to earlier identification and targeted prevention of severe brain bleeding in premature infants, potentially reducing long-term neuro-disabilities.
How similar studies have gone: While the approach of using NIRS for monitoring has shown promise in pilot studies, this specific combination with echocardiography for predicting IVH in ELGANs is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm infants born \<=27+6 weeks gestational age Exclusion Criteria: * Known genetic or congenital anomalies that are likely to affect cardiac or cerebral oxygenation measures * Palliative care plan prior to or immediately following delivery
Where it's running
-
Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting -
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
Study contacts
- Principal investigator: Poorva Deshpande — Mount Sinai Hospital
- Study coordinator: Poorva Deshpande
- Email: poorva.deshpande@sinaihealth.ca
- Phone: 4165864800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.