Intranasal Human Milk for Intraventricular Hemorrhage
Intraventricular Hemorrhage
About this trial
This is an interventional treatment trial for Intraventricular Hemorrhage
Eligibility Criteria
Inclusion Criteria:
1. Preterm infants (<33 weeks gestation at birth, stratified < and ≥28 weeks) with any grade IVH/intraparenchymal hemorrhage/infarction on head ultrasound in the first 10 days of life. Diagnostic criteria will be based on the Papile definitions as used by the study sites/Toronto Centre for Neonatal Health for PHVD management, outlined in the document "Intraventricular Hemorrhage and Measurements of Lateral Ventricular Size from Head Ultrasound"
Exclusion Criteria:
- Disorders associated with neurodevelopmental delays or impairment (i.e. Trisomy 21)
- Moribund/critically ill infant or known lethal diagnosis with plans by medical team to redirect care
- Choanal atresia or anomalies that would not allow intranasal treatment
- Surgical condition (e.g. esophageal atresia) for which team feels intranasal HM is contraindicated
- Enrolled in other intervention trials in which primary target is neurodevelopmental outcome
- Parent with lactation contraindication(s) (i.e. HIV) or parent who declines lactation initiation
- Lactating parent unable to provide fresh HM: unable/unwilling to pump at study site or unable to have fresh HM delivered by designee at least once/day for 3 days within 3 hours of pumping AND located (in hospital or home) >30km from study sites (for courier services)
Sites / Locations
- Mount Sinai Hospital
- The Hospital for Sick Children
Arms of the Study
Arm 1
Experimental
Intranasal human breast milk
Human breast milk delivered intranasally to preterm infants (<33 weeks gestation at birth, stratified < and ≥28 weeks) with any grade IVH/intraparenchymal hemorrhage/infarction identified on head ultrasound in the first 10 days of life. Dosing: Escalating dose starting at 0.2mL into one nostril with repeat dose 10-15 minutes later 1-2x daily, depending on availability of fresh HM