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The CanDo (Canadian Donor Milk) Trial

Type1diabetes | Gestational Diabetes | Small for Gestational Age at Delivery | Type2diabetes

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) 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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    0 to 2

Participation 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).

Study Location

Placenta Clinic
Placenta Clinic
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Jennifer Vaughan

[email protected]
Maternal Fetal Medicine and Placenta clinics
Maternal Fetal Medicine and Placenta clinics
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Natasha Milligan

[email protected]
4165864800
Labour and Delivery at Mount Sinai Hospital
Labour and Delivery at Mount Sinai Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Kim Dart, RN

[email protected]
4165864800
Study Sponsored By
Mount Sinai Hospital, Canada
Participants Required
More Information
Study ID: NCT06315127