Prediction of Intraventricular Hemorrhage Using Echocardiography and Near Infrared Spectroscopy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMount Sinai Hospital, Canada

About this trial

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).

Eligibility criteria

Qualifiers

Preterm infants born <=27+6 weeks gestational age

Disqualifiers

Known genetic or congenital anomalies that are likely to affect cardiac or cerebral oxygenation measures

Palliative care plan prior to or immediately following delivery

Trial design

Treatments tested in this trial

  • Cerebral near-infrared spectroscopy
  • Functional echocardiography
  • Head Ultrasound

Treatment groups

No treatment groups listed

Sponsors and collaborators

Mount Sinai Hospital, Canada

Lead sponsor

London Health Sciences Centre

Collaborator

Foothills Medical Centre

Collaborator

Royal Alexandra Hospital

Collaborator