Predicting brain bleeding in premature infants using echocardiography and near-infrared spectroscopy
Prediction of Intraventricular Hemorrhage Using Echocardiography and Near Infrared Spectroscopy
Mount Sinai Hospital, Canada · NCT05708105
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 |
|---|---|
| Enrollment | 380 (estimated) |
| Sex | All |
| Sponsor | Mount Sinai Hospital, Canada (other) |
| Locations | 4 sites (Calgary, Alberta and 3 other locations) |
| Trial ID | NCT05708105 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born at or before 27 weeks and 6 days of gestational age.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Calgary, Alberta and 3 other locations
- 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)
Study contacts
- Principal investigator: Poorva Deshpande — MOUNT SINAI HOSPITAL
- Study coordinator: Poorva Deshpande
- Email: poorva.deshpande@sinaihealth.ca
- Phone: 4165864800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intraventricular Hemorrhage of Newborn Grade 2, Intraventricular Hemorrhage of Newborn Grade 3, Intraventricular Haemorrhage Grade IV, Near-infrared spectroscopy, Echocardiography, Head ultrasound, Preterm neonates