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Dietary Supplement

Human Donor Milk for Type 1 Diabetes

N/A

Recruiting

Led By Sharon Unger, MD

Research Sponsored by Mount Sinai Hospital, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 2, 3 and 4 months

Awards & highlights

Study Summary

This trial aims to study the effects of using donor milk versus formula to supplement breastfeeding in infants in well-baby units. The researchers want to see if using donor milk or formula during the initial hospital stay

Who is the study for?

This trial is for newborns born to mothers with any type of diabetes or babies who are small for their gestational age (less than 2500 grams). The infants must be in a well-baby unit and require supplementation. Specific inclusion and exclusion criteria details were not provided.Check my eligibility

What is being tested?

The CanDo Trial compares the effects of donor breast milk versus formula on breastfeeding success and infant health outcomes up to 4 months old. Infants will be randomly placed into two groups: one receiving pasteurized donor milk, the other standard formula.See study design

What are the potential side effects?

While specific side effects are not listed, potential concerns may include digestive differences between human milk and formula-fed infants, allergic reactions, or intolerance to either donor milk or formula.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 2, 3 and 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 2, 3 and 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, 3 and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Donor milk supplementation and exclusive breastfeeding rate at 4 months

Secondary outcome measures

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

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

Exploring donor milk supplementation and glucose concentrations during hospital stay

+5 more

Other outcome measures

Exploratory outcome: exploring donor milk supplementation and infant temperament scores

Exploratory outcome: exploring donor milk supplementation and maternal cortisol concentrations

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

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Human Donor MilkExperimental Treatment1 Intervention

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

Group II: Formula supplementActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Human donor milk

2012

N/A

~300

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MitacsIndustry Sponsor

38 Previous Clinical Trials

4,249 Total Patients Enrolled

Mount Sinai Hospital, CanadaLead Sponsor

196 Previous Clinical Trials

67,496 Total Patients Enrolled

Sharon Unger, MDPrincipal InvestigatorSinai Health

1 Previous Clinical Trials

615 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still eligible to participate in this ongoing research?

"Indeed, the information on clinicaltrials.gov confirms that recruitment for this trial is ongoing. The study was initially published on November 28th, 2023 and most recently revised on March 13th, 2024. A total of 112 participants are sought from three distinct sites."

Answered by AI

What is the overall count of individuals participating in this clinical study?

"Indeed, data from clinicaltrials.gov indicates that recruitment for this trial is ongoing. The trial was first listed on 11/28/2023 and last modified on 3/13/2024. Enrollment of 112 participants across three sites is the objective."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The CanDo (Canadian Donor Milk) Trial

Sharon Unger 2023. "The CanDo (Canadian Donor Milk) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06315127.