← Back to all trials
Not Yet Recruiting
NCT05708105
Prediction of Intraventricular Hemorrhage Using Echocardiography and Near Infrared Spectroscopy
Conditions: Intraventricular Hemorrhage of Newborn Grade 2, Intraventricular Hemorrhage of Newborn Grade 3, Intraventricular Haemorrhage Grade IV
Sex: All
Enrollment: 380
Sponsor: Mount Sinai Hospital, Canada
Summary
Moderate-severe intraventricular hemorrhage (Grades II-IV, msIVH) is a significant neurological complication among extremely low gestational age neonates (ELGANs, <27+6 weeks) and is associated with long-term neurodisabilities.
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).
Eligibility Criteria
Inclusion Criteria:Preterm infants born <27+6 weeks gestational ageExclusion Criteria:Known genetic or congenital anomalies that are likely to affect cardiac or cerebral oxygenation measuresPalliative care plan prior to or immediately following delivery
Source: ClinicalTrials.gov (NCT05708105). StuddyBuddy aggregates publicly available trial information.