Prediction of Intraventricular Hemorrhage Using Echocardiography and Near Infrared Spectroscopy

RecruitingOBSERVATIONAL
Enrollment

380

Participants

Timeline

Start Date

April 22, 2024

Primary Completion Date

June 1, 2026

Study Completion Date

November 1, 2027

Conditions
Intraventricular Hemorrhage of Newborn Grade 2Intraventricular Hemorrhage of Newborn Grade 3Intraventricular Haemorrhage Grade IV
Interventions
DIAGNOSTIC_TEST

Cerebral near-infrared spectroscopy

Continuous cerebral NIRS will be monitored using the INVOS 5100C or 7100 Cerebral Oximeter (Medtronic, Minneapolis, MN, USA), initiated as early as feasible after birth or postnatal consent and continued until 48 hours of age. Neonatal sensors applied over a light-permeable barrier will be placed on the right or left side of forehead, like the methods used in our pilot study and in line with our clinical protocol. The continuous parameters recorded for this study using cerebral NIRS will include CrSO2 and COIx.

DIAGNOSTIC_TEST

Functional echocardiography

"The first echocardiogram will be completed as soon as possible after consent and \< 24 hours of age in all cases. This will be to capture markers of early low systemic blood flow and document patent ductus arteriosus and its size, as known to be associated with IVH.~The second scan will be performed at the end of the monitoring period, between 48-60 hours of age. This scan is planned to record the change in LVO from baseline (re-perfusion), which has been postulated to relate to development of IVH."

DIAGNOSTIC_TEST

Head Ultrasound

HUS will be paired with both echocardiograms. The first HUS will document baseline IVH status (paired with the first ECHO). The final HUS will be performed between days 4-7 of age, as per the standard clinical practice by site radiology service and will be used to confirm the final IVH status.

Trial Locations (4)

Unknown

NOT_YET_RECRUITING

Foothillls Medical Centre, Calgary

NOT_YET_RECRUITING

Royal Alexandra Hospital, Edmonton

NOT_YET_RECRUITING

London Health Sciences Centre, London

RECRUITING

Mount Sinai Hospital, Toronto

All Listed Sponsors
collaborator

London Health Sciences Centre

OTHER

collaborator

Foothills Medical Centre

OTHER

collaborator

Royal Alexandra Hospital

OTHER

lead

Mount Sinai Hospital, Canada

OTHER