Active not recruitingNAINTERVENTIONAL

The CanDo (Canadian Donor Milk) Trial

This study, called The CanDo Trial, wants to see if giving human donor milk instead of formula to certain babies helps them breastfeed more and stay healthier. It focuses on babies who might need extra feeds in hospital, such as those whose mothers have diabetes, babies who are born a bit smaller than expected, or those born a little early (late preterm). Researchers want to find out if donor milk can lead to more breastfeeding for longer, and if it positively affects babies' growth, behaviour, feeding success, and even parents' stress levels. Babies joining the study will be split into two groups by chance: one group gets donor milk from a milk bank, and the other gets standard baby formula.

At a glance

Status

Active not recruiting

Phase

Sponsor

Mount Sinai Hospital, Canada

Enrolment target

112

Start

06 Feb 2024

Estimated completion

30 Jun 2026

Small for Gestational Age at Delivery Gestational Diabetes type1diabetes Type2diabetes Late Preterm Infant

What is this study about?

Human breast milk is widely recognised as the best food for babies due to its many health benefits. Sometimes, though, babies need extra milk in hospital because they might have low blood sugar, lose too much weight, or their mother isn't producing enough milk yet. This can happen to quite a few babies, especially those born a little early or with specific health considerations.

Currently, there isn't much clear guidance on whether donor breast milk or formula is better for these babies when they need extra milk. Many hospitals are starting to use donor breast milk more because it shares many health benefits with a mother's own milk. This study aims to help understand this better.

Researchers want to see if babies who receive donor breast milk will breastfeed for longer and more often than those given formula. They will also look at how donor milk or formula might affect babies' weight gain, overall health, how they behave, and how well they feed. Additionally, they're interested in how this choice might impact parents' stress levels.

Key takeaways

This study compares donor breast milk and formula for certain hospitalised newborns.
It aims to find out if donor milk helps babies breastfeed more and stay healthier.
Babies eligible include those whose mothers have diabetes, or who are smaller or born slightly early.
Your baby would be randomly assigned to receive either donor milk or formula.
Researchers will check on your baby's health and feeding until 4 months of age.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for newborn babies who are admitted to the well-baby unit at Sinai Health and whose parents intend to breastfeed. For a baby to be considered for the study, they must also need extra milk feeds.

Specifically, your baby might be eligible if their mother has diabetes (gestational, type 1, or type 2), or if your baby was born a bit smaller than expected for their age (typically less than 2.5 kg at birth, or below the 10th percentile for their age). Babies born a little early, specifically between 35 and 37 weeks of pregnancy, may also qualify.

However, your baby wouldn't be able to join if they're already taking part in another study that affects their feeding, or if there's a plan for a different main caregiver before they are four months old. Also, if they've already received formula before joining the study, or if they have a health condition that would affect their growth, they wouldn't be able to participate. You also need to agree to your baby potentially receiving donor milk.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my baby admitted to the well-baby unit at Sinai Health?
Do I intend to breastfeed my baby?
Does my baby need extra milk feeds in the hospital?
Was I diagnosed with diabetes (gestational, type 1, or type 2) during pregnancy?
Was my baby born smaller than expected (e.g., less than 2.5kg or below the 10th percentile for their gestational age)?
Was my baby born between 35 and 37 weeks of pregnancy (late preterm)?

Answer every question to see your result.

What does participation involve?

If your baby joins this study, they will be randomly placed into one of two groups. One group will receive donor breast milk, and the other will receive standard baby formula. This extra milk will be given in bottles while your baby is in hospital. The study will look at your baby's feeding and health from birth until they are 4 months old.

After leaving the hospital, researchers will keep in touch with you through monthly phone calls for four months. They'll ask about your baby's feeding, health, and development. They might also ask you to fill out questionnaires to learn about your baby's temperament and your own well-being. Some babies might also have tests on their milk at 2 and 4 months.

Potential risks and benefits

Participating in this study could potentially help us understand the best way to support babies who need extra milk, benefiting future families. Your baby will receive high-quality care, either with carefully screened donor milk from a milk bank or standard formula, overseen by medical professionals. As with any medical intervention, there are always very small, theoretical risks, but both donor milk and formula are routinely used and considered safe for babies. You are completely free to withdraw your baby from the study at any time, for any reason, without it affecting your baby's care or your relationship with the medical team.

Locations (3)

Labour and Delivery at Mount Sinai Hospital
Verified postcode
Toronto, Canada
Maternal Fetal Medicine and Placenta clinics
Verified postcode
Toronto, Canada
Placenta Clinic
Verified postcode
Toronto, Canada

Common questions

What is donor milk?

Donor milk is human breast milk that has been kindly donated by other mothers. It is carefully screened, tested, and pasteurised (heated to kill germs) to make it safe for other babies.

Why are only certain babies included in this study?

The study focuses on babies who are more likely to need extra milk, such as those born to mothers with diabetes, those who are a bit smaller, or those born slightly early. These babies may have different needs regarding feeding.

Will I know which type of milk my baby receives?

Yes, you will be informed whether your baby is assigned to receive donor milk or formula for their extra feeds in the hospital.

What if my baby doesn't like the milk they are given?

The medical team will closely monitor your baby's feeding and well-being. If there are any concerns or difficulties, they will discuss options with you.

How long does the study last for my baby?

The intervention (receiving donor milk or formula) happens during your baby's initial hospital stay. The study will then follow up on your baby's health and feeding until they are 4 months old through monthly phone calls.