The CanDo (Canadian Donor Milk) Trial

NCT06315127 | Active Not Recruiting

• 1 other identifier: 23-0119-A
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Donor milk; Exclusive breastfeeding; Infant health outcomes; Mother's milk; feed supplementation; late preterm infant; term infant

Outcome Measures

Primary Outcomes (1)

• Donor milk supplementation and exclusive breastfeeding rate at 4 months

  To determine whether the provision of donor milk as prescribed as a supplement to parent's milk for infants at higher risk for supplementation and admitted to a well-baby unit improves exclusive human milk feeding rate at 4 months of age compared to supplementation with formula.

  At 4 months follow up

Secondary Outcomes (8)

• Exploring donor milk supplementation and exclusive or any breastfeeding rate at 1, 2, and 3 months

  At 1, 2, and 3 months follow ups

• Exploring donor milk supplementation and breastfeeding self-efficacy scores at 1, 2, 3 and 4 months

  At 1, 2, 3, and 4 months follow ups

• Exploring donor milk supplementation and glucose concentrations during hospital stay

  From 2 to 72 hours after delivery or until discharge

• Exploring donor milk supplementation and percent weight loss during hospital stay

  From birth to 72 hours after delivery or until discharge.

• Exploring donor milk supplementation and the length of hospital stay

  From birth to 72 hours after delivery or until discharge

Other Outcomes (4)

• Exploratory outcome: exploring donor milk supplementation and infant temperament scores

  1, 2, 3 and 4 months

• Exploratory outcome: exploring donor milk supplementation and parent's anxiety

  2 and 4 months

• Exploratory outcome: exploring donor milk supplementation and parent's depression

  2 and 4 months

Study Arms (2)

Human Donor Milk

EXPERIMENTAL

All infants in this group will receive pasteurized donor milk from Rogers Hixon Ontario Human Milk Bank if they need extra feeding.

Dietary Supplement: Human donor milk

Formula supplement

ACTIVE COMPARATOR

All infants in this group will receive formula which is the standard of care if they need extra feeding.

Dietary Supplement: Formula

Interventions

Human donor milk DIETARY_SUPPLEMENT

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.

Also known as: Donor milk

Human Donor Milk

Formula DIETARY_SUPPLEMENT

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.

Also known as: Cow's milk based formula

Formula supplement

Eligibility Criteria

• Age: Up to 2 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Late preterm infants born between 35 0/7-36 6/7 weeks of gestational age

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Mitacs: collaborator

Study Sites (3)

Labour and Delivery at Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Maternal Fetal Medicine and Placenta clinics

Toronto, Ontario, M5G 1Z5, Canada

Location

Placenta Clinic

Toronto, Ontario, M5G 1Z5, Canada

Location

Related Publications (4)

• Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.

  PMID: 26869575 BACKGROUND

• Dennis CL, Brown HK, Chung-Lee L, Abbass-Dick J, Shorey S, Marini F, Brennenstuhl S. Prevalence and predictors of exclusive breastfeeding among immigrant and Canadian-born Chinese women. Matern Child Nutr. 2019 Apr;15(2):e12687. doi: 10.1111/mcn.12687. Epub 2018 Oct 4.

  PMID: 30194811 BACKGROUND

• Vehling L, Chan D, McGavock J, Becker AB, Subbarao P, Moraes TJ, Mandhane PJ, Turvey SE, Lefebvre DL, Sears MR, Azad MB. Exclusive breastfeeding in hospital predicts longer breastfeeding duration in Canada: Implications for health equity. Birth. 2018 Dec;45(4):440-449. doi: 10.1111/birt.12345. Epub 2018 Mar 2.

  PMID: 29498088 BACKGROUND

• Belfort MB, Drouin K, Riley JF, Gregory KE, Philipp BL, Parker MG, Sen S. Prevalence and Trends in Donor Milk Use in the Well-Baby Nursery: A Survey of Northeast United States Birth Hospitals. Breastfeed Med. 2018 Jan/Feb;13(1):34-41. doi: 10.1089/bfm.2017.0147. Epub 2017 Oct 24.

  PMID: 29064280 BACKGROUND

Related Links

• Here is the link to the MaxiMOM (Maximizing Mothers Milk for Preterm Babies) studies, of which the CanDo trial is a part.

MeSH Terms

Conditions

Diabetes, Gestational; Breast Feeding

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sharon Unger, MD

  Sinai Health

  PRINCIPAL INVESTIGATOR

• Deborah O'Connor, PhD, RD

  Chair, Department of Nutritional Sciences, University of Toronto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: March 18, 2024
• Study Start: February 6, 2024
• Primary Completion: January 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)