The CanDo (Canadian Donor Milk) Trial

Summary

The goal of this clinical trial is to learn about the impact of donor milk vs formula supplementation on human milk feeding and the health outcomes of infants who require supplementation in well-baby units. It aims to explore whether supplementation with donor milk vs formula for infants during the initial hospital stay in a well-baby unit will increase both the exclusivity and duration of breastfeeding at 4 months. The Investigators will also explore whether the type of supplementation will positively affect measures of newborns' health, growth, behavior, feeding efficacy, and parental stress. Each participating infant born to a diabetic mother OR born small for his/her gestational age (\<2500 grams) OR late preterm (35 0/7-36 6/7 weeks of gestational age) is assigned at random to 2 groups. The groups are: 1) Donor milk: all babies in this group will receive pasteurized donor milk from a trusted milk bank. 2) Formula: all babies in this group will receive formula as a standard of care.

Conditions

• Small for Gestational Age at Delivery
• Gestational Diabetes
• type1diabetes
• Type2diabetes
• Late Preterm Infant

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.

Sponsors & Collaborators

• Mitacs

  collaborator INDUSTRY

• Mount Sinai Hospital, Canada

  lead OTHER

Principal Investigators

• Sharon Unger, MD · Sinai Health

• Deborah O'Connor, PhD, RD · Chair, Department of Nutritional Sciences, University of Toronto

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

2 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-06

Primary Completion

2026-01-30

Completion

2026-06-30

Countries

• Canada

Study Locations