Condition: Intraventricular Hemorrhage of Newborn Grade 2 · Intraventricular Hemorrhage of Newborn Grade 3 · Intraventricular Haemorrhage Grade IV · Sponsor: Mount Sinai Hospital, Canada
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 r…
This description comes directly from the study's public registry record.
Poorva Deshpande · 4165864800 · poorva.deshpande@sinaihealth.ca
Laura Thomas, MSc · 4165864800 · laura.thomas@sinaihealth.ca
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT05708105