Comparing donor milk and formula for infants needing supplementation
The CanDo (Canadian Donor Milk) Trial: Pasteurized Human Donor Milk Supplementation in the Well-baby Unit
This study is testing whether feeding infants donor milk or formula helps them grow better and supports breastfeeding, especially for babies born to diabetic mothers or those who are smaller than expected.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | N/A to 2 Hours |
| Sex | All |
| Sponsor | Mount Sinai Hospital, Canada Academic / other |
| Locations | 3 sites (Toronto, Ontario and 2 other locations) |
| Trial ID | NCT06315127 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of donor milk versus formula supplementation on the health outcomes of infants in well-baby units who require additional feeding support. Infants born to diabetic mothers or those classified as small for gestational age will be randomly assigned to receive either pasteurized donor milk or formula during their hospital stay. The study aims to assess the impact of these feeding methods on breastfeeding exclusivity and duration, as well as various health measures such as growth, behavior, and parental stress. The trial will also evaluate the effects on infant temperament and parental mental health over the first four months.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born to diabetic mothers or those classified as small for gestational age who require supplementation in a well-baby unit.
Not a fit: Patients who may not benefit from this study include those enrolled in other clinical studies affecting nutritional management or those with conditions impacting growth.
Why it matters
Potential benefit: If successful, this study could enhance breastfeeding rates and improve health outcomes for vulnerable infants requiring supplementation.
How similar studies have performed: Previous studies have shown positive outcomes with donor milk supplementation in preterm infants, suggesting potential benefits for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Infants admitted to the well-baby unit at Sinai Health whose parent(s) intend to feed parent milk and who require supplementation: * Infants of gestational/ type 1/ type 2 diabetic mothers * Infants who are born small for gestational age (SGA) by using a sex-specific reference population and determining if their birth weight falls below the 10th percentile for gestational age * Infants with a birth weight less than 2.5 kg Exclusion Criteria: * Enrollment in any other clinical study affecting nutritional management during the feeding intervention; anticipated change in primary caregiver (person providing the feed) prior to 4 months; refusal to consent to donor milk; supplementation with formula prior to enrollment; any physical condition that may impact growth (ex: skeletal dysplasia).
Where this trial is running
Toronto, Ontario and 2 other locations
- Labour and Delivery at Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
- Maternal Fetal Medicine and Placenta clinics — Toronto, Ontario, Canada (Recruiting)
- Placenta Clinic — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Sharon Unger, MD — Sinai Health
- Study coordinator: Maryam Razaghi, PhD
- Email: maryam.razaghi@utoronto.ca
- Phone: 4373356368
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.