The CanDo (Canadian Donor Milk) Trial

NARecruitingINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

November 28, 2023

Primary Completion Date

November 28, 2024

Study Completion Date

March 31, 2025

Conditions
Small for Gestational Age at DeliveryGestational Diabetestype1diabetesType2diabetes
Interventions
DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Trial Locations (3)

M5G 1X5

RECRUITING

Labour and Delivery at Mount Sinai Hospital, Toronto

M5G 1Z5

RECRUITING

Maternal Fetal Medicine and Placenta clinics, Toronto

RECRUITING

Placenta Clinic, Toronto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mitacs

INDUSTRY

lead

Mount Sinai Hospital, Canada

OTHER