Mother's milk is recognized as the nutritional gold standard for newborn feeding, yet supplementation during the postnatal hospital stay remains common. In Canadian well-baby units, supplementation rates range from 35% to 50% despite lactation support. When supplementation is required, the choice between infant formula and pasteurised human donor milk (referred to here as donor milk) lacks robust trial evidence to guide practice. The CanDo trial was developed to address this evidence gap by comparing donor milk and formula as supplements to mother's own milk for infants at higher risk of requiring supplementation.
CanDo is an ongoing, open-label, single-centre, randomised controlled trial conducted at Mount Sinai Hospital in Toronto, Canada. The protocol randomises infants when supplementation is judged necessary by families and/or the healthcare team during the infant's initial hospital stay. The study will enrol a total of 112 infants, with 56 allocated to the donor milk arm and 56 to the formula arm.
The trial targets newborns at increased risk of needing supplementation. Eligible infants include:
These groups were selected because they have higher observed rates of in-hospital milk supplementation and may particularly benefit from evidence to inform the supplement choice.
When supplementation is deemed necessary during the initial hospital stay, enrolled infants are randomised to receive either pasteurised donor milk or infant formula as the supplemental feed in addition to mother's own milk. The trial is open-label, so families and clinical staff are aware of the assigned supplement. The intervention period covers the initial hospital admission during which supplementation occurs.
Primary outcome:
Secondary outcomes:
Exploratory outcomes:
These outcomes allow assessment of both feeding practices and broader infant and family well-being measures associated with the supplement choice.
Participants will be followed with monthly telephone assessments throughout the first four months postpartum. A planned virtual or in-person visit will occur at 4 months postpartum to collect primary outcome data and secondary and exploratory measures that require direct assessment. Data collection includes feeding status at specified time points, growth and health indicators, breastfeeding self-efficacy, and the exploratory psychobiological and behavioral measures noted above.
The trial plans to enrol 112 infants (56 per group). Data will be analysed according to intention-to-treat principles. The protocol specifies comparison of the primary outcome—exclusive human milk feeding at 4 months—between the donor milk and formula-supplemented groups, with additional analyses for secondary and exploratory outcomes. The source did not provide further statistical detail such as power calculations, alpha thresholds, or planned covariate adjustments; those details were not reported in the available protocol summary.
The CanDo trial has received ethics approval from the Mount Sinai Hospital Research Ethics Board and the University of Toronto. The study is registered under trial number NCT06315127. Results are planned for dissemination through peer-reviewed journal publications, conference presentations, and stakeholder engagement with hospital and public health decision-makers. The investigators state that 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 for newborn feeding.
CanDo is a single-centre, open-label randomized trial comparing pasteurised donor milk versus infant formula as supplementation to mother's milk for infants at higher risk of requiring supplemental feeds. With a primary endpoint of exclusive human milk feeding at 4 months and multiple secondary and exploratory outcomes assessing feeding, growth, and parental mental health, the trial aims to provide evidence to guide supplement choice in well-baby units. Ethics approvals are in place and dissemination plans include academic and stakeholder channels. Details on some statistical planning elements were not reported in the source summary.