Small for Gestational Age at DeliveryNCT06315127
The CanDo (Canadian Donor Milk) Trial
A study testing Human donor milk and Formula in people with Small for Gestational Age at Delivery and Gestational Diabetes, run by Mount Sinai Hospital, Canada at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 hours
- Conditions the study is for
- Small for Gestational Age at Delivery, Gestational Diabetes, type1diabetes
- What is being tested?
- Human donor milk and Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 3 sitesCanada
- Study dates
- 6 Feb 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Labour and Delivery at Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Maternal Fetal Medicine and Placenta clinics
Toronto, Ontario, M5G 1Z5
Placenta Clinic
Toronto, Ontario, M5G 1Z5
About this study
Official title: The CanDo (Canadian Donor Milk) Trial: Pasteurized Human Donor Milk Supplementation in the Well-baby Unit
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.
Read the detailed description
Background and Importance: Human milk is the ideal nutrition for all infants, and research has demonstrated that human donor milk can provide health benefits for preterm infants. Approximately 35-50% of late preterm and term infants admitted to a well-baby unit after birth require supplementation due to various reasons including hypoglycemia, weight loss, or insufficient availability of parent's milk. However, there is limited research to guide decision making on which supplement to prescribe. Despite this, many hospitals are introducing donor milk in well-baby units in light of the growing recognition of the health protective effects of human milk.
Goals/ Research Aims: The primary research aim of this study is to compare the effects of supplementing parent's milk with donor milk versus formula in infants at increased risk for supplementation (infant born to a mother with diabetes, infant with a birth weight smaller than expected for the gestational age (SGA)) on exclusive human milk feeding at 4 months of age. Secondary research aims include: examining the effects of supplementing parent's milk with donor milk on any or exclusive human milk feeding rates at 1, 2 and 3 months, infant health and growth at hospital discharge and at 1, 2, 3, and 4 months, and breast feeding self-efficacy scores. Exploratory outcomes include: infant temperament scores at 1, 2, 3, and 4 months, and parental mental health scores at 2 and 4 months using validated questionaires, milk cortisol concentrations at 2 and 4 months, the use of informally shared milk, and the associated financial costs of a donor milk program versus formula.
Methods/ Approaches/ Expertise: This proposed study is a randomized, controlled, single-center trial that will involve assigning participants to two intervention arms (n=56 infants/arm). The intervention will involve providing donor milk or formula in bottles and will last for the duration of the infant's initial hospitalization, followed by monthly phone calls and a virtual or in-person assessment at 4 months. At each time-point of 1, 2, 3, and 4-month, surveys of breast feeding self-efficacy, and health and infant temparement will be conducted, and the infant's anthropometrics will be measured. Additionally, measures of parental depression, anxiety and stress will be assessed with survey-based tools at 2 and 4 months. A coincident human milk sample will be collected at 2 and 4 months and will be analysed for cortisol concentrations. The research team has experience running feeding interventions and donor milk trials in newborns, and includes experts in nursing, medicine, dietetics, and milk banking.
Expected Outcomes: This proposed research holds the potential to make a meaningful impact on public health. In Canada, with approximately 350,000 level I nursery admissions each year and high rates of formula supplementation ranging from 35-50%, there is a clear opportunity for improvement. By promoting exclusive human milk feeding, exploring evidence-based practices to inform hospital guidelines, and reducing the reliance on informal milk sharing, this research aims to enhance the health outcomes for both parents and infants. Additionally, it seeks to deepen the understanding of early parent-child interactions, fostering greater awareness and knowledge in this area.
- Conditions
- Small for Gestational Age at Delivery, Gestational Diabetes, type1diabetes, Type2diabetes, Late Preterm Infant
- Being tested
- Human donor milk, Formula
- Keywords
- Donor milk, Exclusive breastfeeding, Infant health outcomes, Mother's milk, feed supplementation, late preterm infant, term infant
- Medical subject headings
- Diabetes, Gestational, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human donor milkDietary supplement
Also called Donor milk
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.
FormulaDietary supplement
Also called Cow's milk based formula
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 4 months follow up
Secondary outcomes (8)
Exploring donor milk supplementation and exclusive or any breastfeeding rate at 1, 2, and 3 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 any, or exclusive, human milk feeding rates at 1, 2, and 3 months of age rate compared to supplementation with formula.
Measured: At 1, 2, and 3 months follow ups
Exploring donor milk supplementation and breastfeeding self-efficacy scores at 1, 2, 3 and 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 breastfeeding self-efficacy scores at 1, 2, 3, and 4 months compared to supplementation with formula. Breastfeeding Self-Efficacy Scale - Short Form, BSES-SF will be used which consists of 14 items scored on a 5-point Likert scale ranging from not at all confident to always confident. Individuals who score higher on the BSES-SF are expressing more confidence in their ability to breastfeed successfully.
Measured: At 1, 2, 3, and 4 months follow ups
Exploring donor milk supplementation and glucose concentrations during hospital stay
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 hypoglycemia in infants compared to supplementation with formula. Glucose concentrations during hospital stay and at discharge will be extracted from patient charts and compared between groups.
Measured: From 2 to 72 hours after delivery or until discharge
Exploring donor milk supplementation and percent weight loss during hospital stay
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 weight loss in infants compared to supplementation with formula. Infant weight during the hospital stay and at discharge will be extracted from patient charts and percent weight loss will be compared between groups.
Measured: From birth to 72 hours after delivery or until discharge.
Exploring donor milk supplementation and the length of hospital stay
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 affects their length of hospital stay compared to supplementation with formula.
Measured: From birth to 72 hours after delivery or until discharge
Exploring donor milk supplementation and weight measurements
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 affects their weight compared to supplementation with formula at 1, 2, 3, and 4 months using standardized procedures including mechanical scales.
Measured: 1, 2, 3, and 4 months
Exploring donor milk supplementation and length measurements
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 affects their length compared to supplementation with formula at 1, 2, 3, and 4 months using standardized procedures including length boards.
Measured: 1, 2, 3, and 4 months
Exploring donor milk supplementation and head circumference measurements
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 affects their head circumference compared to supplementation with formula at 1, 2, 3, and 4 months using standardized procedures including non-stretchable measuring tapes.
Measured: 1, 2, 3, and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start6 Feb 2024
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Small for Gestational Age at DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs
- Responsible party
- Principal investigator, Sharon Unger, Mount Sinai Hospital, Canada
- Investigators
- Sharon Unger, MD, Principal investigator, Sinai HealthDeborah O'Connor, PhD, RD, Study director, Chair, Department of Nutritional Sciences, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315127
- Sponsor's protocol ID
- 23-0119-A
- Status last verified
- Nov 2025
- First submitted
- 10 Nov 2023
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All information collected during this study, including individual participant's personal health information, will be kept confidential and will not be shared with anyone outside the study unless required by law. Participants will not be named in any reports, publications, or presentations that may come from this study.
Publications
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.
PubMed 26869575Dennis 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.
PubMed 30194811Vehling 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.
PubMed 29498088Belfort 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.
PubMed 29064280Razaghi M, O'Connor DL, Shah J, Leibson T, Dart K, Da Silva N, O'born E, Kiss A, Stone D, Unger S. CanDo (Canadian Donor Milk) randomised controlled trial: pasteurised human donor milk supplementation in the well-baby unit - protocol. BMJ Open. 2026 Sep 15;16(9):e114973. doi: 10.1136/bmjopen-2025-114973.
PubMed 42744366
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CanDo (Canadian Donor Milk) Trial: Pasteurized Human Donor Milk Supplementation in the Well-baby Unit
- ClinicalTrials.gov ID
- NCT06315127
- Acronym / sponsor ID
- 23-0119-A
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Mitacs
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Importance: Human milk is the ideal nutrition for all infants, and research has demonstrated that human donor milk can provide health benefits for preterm infants. Approximately 35-50% of late preterm and term infants admitted to a well-baby unit after birth require supplementation due to various reasons including hypoglycemia, weight loss, or insufficient availability of parent's milk. However, there is limited research to guide decision making on which supplement to prescribe. Despite this, many hospitals are introducing donor milk in well-baby units in light of the growing recognition of the health protective effects of human milk.
Goals/ Research Aims: The primary research aim of this study is to compare the effects of supplementing parent's milk with donor milk versus formula in infants at increased risk for supplementation (infant born to a mother with diabetes, infant with a birth weight smaller than expected for the gestational age (SGA)) on exclusive human milk feeding at 4 months of age. Secondary research aims include: examining the effects of supplementing parent's milk with donor milk on any or exclusive human milk feeding rates at 1, 2 and 3 months, infant health and growth at hospital discharge and at 1, 2, 3, and 4 months, and breast feeding self-efficacy scores. Exploratory outcomes include: infant temperament scores at 1, 2, 3, and 4 months, and parental mental health scores at 2 and 4 months using validated questionaires, milk cortisol concentrations at 2 and 4 months, the use of informally shared milk, and the associated financial costs of a donor milk program versus formula.
Methods/ Approaches/ Expertise: This proposed study is a randomized, controlled, single-center trial that will involve assigning participants to two intervention arms (n=56 infants/arm). The intervention will involve providing donor milk or formula in bottles and will last for the duration of the infant's initial hospitalization, followed by monthly phone calls and a virtual or in-person assessment at 4 months. At each time-point of 1, 2, 3, and 4-month, surveys of breast feeding self-efficacy, and health and infant temparement will be conducted, and the infant's anthropometrics will be measured. Additionally, measures of parental depression, anxiety and stress will be assessed with survey-based tools at 2 and 4 months. A coincident human milk sample will be collected at 2 and 4 months and will be analysed for cortisol concentrations. The research team has experience running feeding interventions and donor milk trials in newborns, and includes experts in nursing, medicine, dietetics, and milk banking.
Expected Outcomes: This proposed research holds the potential to make a meaningful impact on public health. In Canada, with approximately 350,000 level I nursery admissions each year and high rates of formula supplementation ranging from 35-50%, there is a clear opportunity for improvement. By promoting exclusive human milk feeding, exploring evidence-based practices to inform hospital guidelines, and reducing the reliance on informal milk sharing, this research aims to enhance the health outcomes for both parents and infants. Additionally, it seeks to deepen the understanding of early parent-child interactions, fostering greater awareness and knowledge in this area.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Donor Milk | Experimental | Dietary Supplement: Human donor milkAll infants in this group will receive pasteurized donor milk from Rogers Hixon Ontario Human Milk Bank if they need extra feeding. |
| Formula supplement | Active comparator | Dietary Supplement: FormulaAll infants in this group will receive formula which is the standard of care if they need extra feeding. |
Who may qualify
- Ages
- Up to 2 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human donor milkAlso: Donor milkThe 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. | Dietary supplement | Human Donor Milk |
| FormulaAlso: Cow's milk based formulaThe 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. | Dietary supplement | Formula supplement |
Primary outcome
Donor milk supplementation and exclusive breastfeeding rate at 4 months
Time frame: At 4 months follow up
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.
8 secondary outcomes
Exploring donor milk supplementation and exclusive or any breastfeeding rate at 1, 2, and 3 months
Time frame: At 1, 2, and 3 months follow ups
Exploring donor milk supplementation and breastfeeding self-efficacy scores at 1, 2, 3 and 4 months
Time frame: At 1, 2, 3, and 4 months follow ups
Exploring donor milk supplementation and glucose concentrations during hospital stay
Time frame: From 2 to 72 hours after delivery or until discharge
Exploring donor milk supplementation and percent weight loss during hospital stay
Time frame: From birth to 72 hours after delivery or until discharge.
Exploring donor milk supplementation and the length of hospital stay
Time frame: From birth to 72 hours after delivery or until discharge
Exploring donor milk supplementation and weight measurements
Time frame: 1, 2, 3, and 4 months
Exploring donor milk supplementation and length measurements
Time frame: 1, 2, 3, and 4 months
Exploring donor milk supplementation and head circumference measurements
Time frame: 1, 2, 3, and 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 26869575Victora 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.
- Background: PubMed 30194811Dennis 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.
- Background: PubMed 29498088Vehling 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.
- Background: PubMed 29064280Belfort 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.
- Derived from this study: PubMed 42744366Razaghi M, O'Connor DL, Shah J, Leibson T, Dart K, Da Silva N, O'born E, Kiss A, Stone D, Unger S. CanDo (Canadian Donor Milk) randomised controlled trial: pasteurised human donor milk supplementation in the well-baby unit - protocol. BMJ Open. 2026 Sep 15;16(9):e114973. doi: 10.1136/bmjopen-2025-114973.
- Here is the link to the MaxiMOM (Maximizing Mothers Milk for Preterm Babies) studies, of which the CanDo trial is a part.Link provided by the sponsor.
- Individual participant dataSharing planned: No. All information collected during this study, including individual participant's personal health information, will be kept confidential and will not be shared with anyone outside the study unless required by law. Participants will not be named in any reports, publications, or presentations that may come from this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Unger, MD principal investigator
Sinai Health
Deborah O'Connor, PhD, RD study director
Chair, Department of Nutritional Sciences, University of Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human donor milk and Formula in people with Small for Gestational Age at Delivery and Gestational Diabetes, run by Mount Sinai Hospital, Canada at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donor milk supplementation and exclusive breastfeeding rate at 4 months (time frame: At 4 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06315127, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.