112
Participants
Start Date
November 28, 2023
Primary Completion Date
November 28, 2024
Study Completion Date
March 31, 2025
Human donor milk
The intervention will involve providing donor milk as required as a supplement to parent milk and will last for the duration of the infant's initial hospitalization. The intervention will continue throughout the hospitalization at any time that supplementation is recommended by the clinical team, and is expected to last from 0 to 72 hours post-birth. All donor milk will be aliquoted into individualized syringes in the Rogers Hixon Ontario Human Milk Bank which is located in Sinai Health. The decision regarding the timing and duration of the supplementation will be determined by the medical team in the well-baby unit based on the specific needs and circumstances of each mother-infant dyad. As this study follows a pragmatic approach, the clinical team will assess the need for supplementation based on the mother-infant dyad's condition.
Formula
The intervention will involve providing formula as required as a supplement to parent milk and as a standard of care, and will last for the duration of the infant's initial hospitalization. The intervention will continue throughout the hospitalization at any time that supplementation is recommended by the clinical team, and is expected to last from 0 to 72 hours post-birth. The formula will be supplied from the hospital's inventory in accordance with the standard procedure followed by the well-baby unit to supplement infants. The decision regarding the timing and duration of the supplementation will be determined by the medical team in the well-baby unit based on the specific needs and circumstances of each mother-infant dyad.
RECRUITING
Labour and Delivery at Mount Sinai Hospital, Toronto
RECRUITING
Maternal Fetal Medicine and Placenta clinics, Toronto
RECRUITING
Placenta Clinic, Toronto
Collaborators (1)
Mitacs
INDUSTRY
Mount Sinai Hospital, Canada
OTHER