Matching Donor Human Milk On Maternal Secretor Status (MMOMSS) Study

NCT04130165 | Suspended

• 1 other identifier: REB19-0542
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 receive donor human milk which is matched their mother's secretor status and half will receive standard (unmatched) donor human milk, which is standard care in the neonatal intensive care unit.

Conditions

Microbial Colonization; Preterm Birth

Keywords

preterm infants; human milk; microbiome; donor human milk; breastmilk

Outcome Measures

Primary Outcomes (1)

• Fecal microbiome composition

  16S RNA sequencing of fecal bacteria

  sampled weekly until infant transferred from level III NICU, they are no longer receiving donor human milk or up to 60 days, whichever comes first.

Other Outcomes (9)

• Growth - weight

  sampled weekly until infant transferred from level III NICU, they are no longer receiving donor human milk or up to 60 days, whichever comes first.

• Growth - length

  sampled weekly until infant transferred from level III NICU, they are no longer receiving donor human milk or up to 60 days, whichever comes first.

• Growth - head circumference

  sampled weekly until infant transferred from level III NICU, they are no longer receiving donor human milk or up to 60 days, whichever comes first.

Study Arms (2)

Matched donor human milk

EXPERIMENTAL

Infants randomized to the matched donor human milk arm, will receive donor human milk which is matched to their mother's secretor status.

Other: Matched donor human milk

Standard issue donor human milk

NO 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.

Interventions

Matched donor human milk OTHER

Milk from donor mothers will be sorted according to their secretor status. This milk will be provided to infants in the intervention (experimental) arm.

Matched donor human milk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• University of Calgary: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, Canada

Location

Related Publications (5)

• Azad MB, Robertson B, Atakora F, Becker AB, Subbarao P, Moraes TJ, Mandhane PJ, Turvey SE, Lefebvre DL, Sears MR, Bode L. Human Milk Oligosaccharide Concentrations Are Associated with Multiple Fixed and Modifiable Maternal Characteristics, Environmental Factors, and Feeding Practices. J Nutr. 2018 Nov 1;148(11):1733-1742. doi: 10.1093/jn/nxy175.

  PMID: 30247646 BACKGROUND

• Bode L. Human milk oligosaccharides: every baby needs a sugar mama. Glycobiology. 2012 Sep;22(9):1147-62. doi: 10.1093/glycob/cws074. Epub 2012 Apr 18.

  PMID: 22513036 BACKGROUND

• Marx C, Bridge R, Wolf AK, Rich W, Kim JH, Bode L. Human milk oligosaccharide composition differs between donor milk and mother's own milk in the NICU. J Hum Lact. 2014 Feb;30(1):54-61. doi: 10.1177/0890334413513923. Epub 2013 Nov 26.

  PMID: 24282194 BACKGROUND

• Parra-Llorca A, Gormaz M, Alcantara C, Cernada M, Nunez-Ramiro A, Vento M, Collado MC. Preterm Gut Microbiome Depending on Feeding Type: Significance of Donor Human Milk. Front Microbiol. 2018 Jun 27;9:1376. doi: 10.3389/fmicb.2018.01376. eCollection 2018.

  PMID: 29997594 BACKGROUND

• Lewis ZT, Totten SM, Smilowitz JT, Popovic M, Parker E, Lemay DG, Van Tassell ML, Miller MJ, Jin YS, German JB, Lebrilla CB, Mills DA. Maternal fucosyltransferase 2 status affects the gut bifidobacterial communities of breastfed infants. Microbiome. 2015 Apr 10;3:13. doi: 10.1186/s40168-015-0071-z. eCollection 2015.

  PMID: 25922665 BACKGROUND

Related Links

• Lab Website

MeSH Terms

Conditions

Communicable Diseases; Premature Birth

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Meghan B Azad, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor (lab technician/research assistant) will not be aware of the group allocation or nutritional intake of the infant while completing data analysis. We cannot blind participants or care providers as provision of matched donor human milk will require preparation which deviates from standard protocol, and the bedside nurse will need to conduct this preparation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pilot Randomized Control Trial

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 17, 2019
• Study Start: May 29, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)