---
title: "CanDo RCT: Donor Milk vs Formula Supplementation in Canadian Well-Baby Units"
id: "bmj-open-3-cando-canadian-donor-milk-randomised-controlled-trial-pasteurised-human-donor"
canonical_url: "https://medichelpline.com/clinical-feed/bmj-open-3-cando-canadian-donor-milk-randomised-controlled-trial-pasteurised-human-donor"
content_type: "clinical_feed_article"
specialty: "Pediatrics"
source_name: "BMJ Open"
source_url: "http://bmjopen.bmj.com/cgi/content/short/16/9/e114973?rss=1"
published_at: "2026-09-15T12:32:32.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# CanDo RCT: Donor Milk vs Formula Supplementation in Canadian Well-Baby Units
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/bmj-open-3-cando-canadian-donor-milk-randomised-controlled-trial-pasteurised-human-donor
- **Specialty:** [Pediatrics](https://medichelpline.com/clinical-feed/pediatrics.md)
- **Primary Source:** BMJ Open
- **Source URL:** [Original Journal Publication](http://bmjopen.bmj.com/cgi/content/short/16/9/e114973?rss=1)
- **Published At:** 2026-09-15T12:32:32.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- The CanDo trial is an ongoing, open-label, single-centre **randomised controlled trial** at Mount Sinai Hospital, Toronto, comparing pasteurised **donor milk** versus infant formula as supplements to mother's milk in the well-baby unit. - The trial targets infants at higher risk for supplementation: infants of diabetic mothers, infants born small for gestational age or with birth weight <2.5 kg, and late preterm infants (35 0/7 to 36 6/7 weeks gestation). - Enrollment aims for 112 infants total, randomized 1:1 to donor milk (n=56) or formula (n=56) when supplementation is deemed necessary by family and/or healthcare team during initial hospital stay. - The primary outcome is **exclusive human milk feeding** at 4 months of age. Secondary outcomes include any or exclusive human milk feeding at 1, 2 and 3 months, infant growth, health indicators, and breastfeeding self-efficacy. - Exploratory outcomes include infant temperament, parental mental health (State-Trait Anxiety Inventory and Edinburgh Postnatal Depression Scale), milk cortisol concentrations, and informal milk sharing patterns comparing the two supplement groups. - Follow-up comprises monthly telephone assessments and a virtual or in-person visit at 4 months postpartum; analysis will follow intention-to-treat principles. - The trial has research ethics approval from Mount Sinai Hospital Research Ethics Board and the University of Toronto and is registered under NCT06315127. - Results will be disseminated via peer-reviewed journals, conferences, and stakeholder engagement to inform clinical practice and policy on the use of donor milk in well-baby units.
## Clinical Analysis & Structured Key Points
Introduction Mother's milk is the gold standard for feeding newborns. Despite lactation support while in hospital, supplementation rates remain high in Canadian well-baby units at 35 - 50%. When supplementation is needed, the choice between formula milk and pasteurised human donor milk (donor milk) remains uncertain with a lack of clinical trials to inform this practice. This study aims to compare the effect of supplementing mother's milk with donor milk versus formula in infants at higher risk for supplementation (infants of diabetic mothers, infants born small for gestational age or with a birth weight less than 2.5 kg and late preterm infants born between 35 0/7 and 36 6/7 weeks gestation). Methods and analysis This is an ongoing, open-label, single-centre, randomised controlled trial conducted at Mount Sinai Hospital, Toronto, Canada. A total of 112 infants (56 per group) will be randomised to receive donor milk or infant formula as a supplement to mother's milk during their initial hospital stay, when supplementation is deemed necessary by the family and/or healthcare team. The primary outcome is exclusive human milk feeding at 4 months of age. Secondary outcomes include any or exclusive human milk feeding at 1, 2 and 3 months; infant growth and health indicators and breastfeeding self-efficacy. Exploratory outcomes encompass infant temperament; parental mental health (assessed using the State-Trait Anxiety Inventory and Edinburgh Postnatal Depression Scale); milk cortisol concentrations; and informal milk sharing comparing donor milk and formula supplementation. Follow-up includes monthly telephone assessments and a virtual or in-person visit at 4 months post partum. Data will be analysed using intention-to-treat principles. Ethics and dissemination The CanDo trial has received ethics approval from the Mount Sinai Hospital Research Ethics Board and the University of Toronto. Results will be disseminated through peer-reviewed journals, conference presentations and stakeholder engagement with hospital and public health decision-makers. Findings will address a critical evidence gap regarding the use of donor milk supplementation in well-baby units and may inform future clinical practice and policy in newborn feeding. Trial registration number NCT06315127 .
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