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Matched Donor Human Milk for Premature Birth (MMOMSS Trial)
N/A
Recruiting
Led By Meghan B Azad, PhD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured when infant is discharged or transferred from unit, or up to 60 days, whichever comes first.
Awards & highlights
MMOMSS Trial Summary
This trial will study whether matching a preterm infant's donor milk to their mother's secretor status impacts the gut microbiome.
Who is the study for?
This trial is for very preterm infants born before 34 weeks of gestation. Eligible babies must be able to receive donor human milk and have mothers who can consent and comply with the study's requirements. Infants with a high risk of not surviving, serious gut conditions like NEC, or those on long-term antibiotics are excluded.Check my eligibility
What is being tested?
The MMOMSS Study is testing whether matching donated breast milk to an infant's mother's secretor status affects the baby’s gut bacteria. Preterm infants will either get matched donor milk or standard unmatched donor milk in this randomized control trial.See study design
What are the potential side effects?
Since the intervention involves feeding with human breast milk, side effects may be minimal but could include potential allergic reactions or intolerance to certain components in the donor milk.
MMOMSS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured when infant is discharged or transferred from unit, or up to 60 days, whichever comes first.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured when infant is discharged or transferred from unit, or up to 60 days, whichever comes first.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fecal microbiome composition
Other outcome measures
Days to full enteral feeds
Donor human milk composition - human milk oligosaccharide concentrations
Donor human milk composition - nutritional composition
+6 moreMMOMSS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Matched donor human milkExperimental Treatment1 Intervention
Infants randomized to the matched donor human milk arm, will receive donor human milk which is matched to their mother's secretor status.
Group II: Standard issue donor human milkActive Control1 Intervention
Infants randomized to the standard issue donor human milk arm, will receive donor human milk which is prepared without consideration of secretor status as per standard practice.
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,421 Total Patients Enrolled
10 Trials studying Premature Birth
1,506 Patients Enrolled for Premature Birth
University of CalgaryOTHER
792 Previous Clinical Trials
869,094 Total Patients Enrolled
18 Trials studying Premature Birth
14,666 Patients Enrolled for Premature Birth
Meghan B Azad, PhDPrincipal InvestigatorUniversity of Manitoba
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant is not on long-term antibiotics beyond the standard 48-hour newborn care.I have had an intestinal perforation or stage 2 necrotizing enterocolitis.You were born with a serious physical abnormality.It is unlikely that you will live long enough to complete the study.I had a bowel perforation or severe intestinal infection before starting solid foods.I am admitted to the hospital and my pregnancy is up to 33 weeks and 6 days.
Research Study Groups:
This trial has the following groups:- Group 1: Standard issue donor human milk
- Group 2: Matched donor human milk
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for patients to participate in this experiment?
"As evidenced by clinicaltrials.gov, this medication trial is not presently recruiting participants. Initially posted on December 1st 2022 and last updated November 10th of the same year, no new applicants are being accepted at present. However, there are over a thousand other studies taking part in patient recruitment right now."
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