Status:
SUSPENDED
Matching Donor Human Milk On Maternal Secretor Status (MMOMSS) Study
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
University of Calgary
Conditions:
Microbial Colonization
Preterm Birth
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate the impact of matching donor human milk to the maternal secretor status of very preterm infants (\<34 weeks gestation) on the gut microbiome. Half of enrolled infants will rec...
Detailed Description
Background: The gut microbiome is established early in life and plays an important role in developing the immune system and metabolism. Infants born prematurely (before 37-weeks gestation) account for...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Gestation up to 33 6/7 weeks at hospital admission (to guarantee at least 14 days intervention, since DHM fortification typically ends at 34+0 weeks adjusted gestational age).
- Provision of consent for infant to receive DHM.
- Mother has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
- In the investigator's opinion, the subject mother understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.
- Exclusion Criteria (Infant):
- Diagnosed with clinically significant major congenital malformation
- Intestinal perforation or stage 2 necrotizing enterocolitis (NEC)
- Unlikely to survive the study period
- Receiving extended courses of antibiotics (most infants are expected to receive up to 48hr antibiotic prophylaxis at birth according to standard NICU protocol; this criterion will only exclude infants receiving prolonged courses of antibiotics)
- Presence prior to enrollment of intestinal perforation or stage 2 necrotizing enterocolitis (NEC) prior to tolerating fortified feeds
Exclusion
Key Trial Info
Start Date :
May 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04130165
Start Date
May 29 2023
End Date
December 31 2025
Last Update
December 6 2024
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada