Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
MaxiMoM: Individualized Fortification of Human Milk for Infants Born ≤ 1250 g; a Three Arm Randomized Clinical Trial
1 other identifier
interventional
615
1 country
20
Brief Summary
Very low birth weight infants have increased nutritional needs. Extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment. Standard fortification of human milk is routine in most neonatal units in North America, but despite the added nutrients, infants are often discharged from hospitals with poor growth, and their neurodevelopment remains suboptimal. Two individualized fortification methods, target and BUN adjustable, have been proposed to improve the nutrient supply to infants. However, there is currently insufficient evidence to support the implementation of individualized fortification or one method over the other. Therefore, this study will randomly assign very low birth weight infants to receive feeds fortified according to standard, target or BUN adjustable fortification methods until the end of the feeding intervention. Feedings will be prepared in milk preparation rooms to ensure caregivers and outcomes assessor remain blinded to feeding allocation. Growth, morbidities, and nutrient intakes will be determined throughout hospitalization and skinfolds assessed at 36 weeks. At 4 months CA, growth and body composition will be determined by air displacement plethysmography on a subset of infants. Neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development, at 18-24 months CA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2021
CompletedStudy Start
First participant enrolled
November 11, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
July 31, 2025
July 1, 2025
4.6 years
November 10, 2021
July 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Cognitive Composite Score
Bayley Scales of Infant and Toddler Development
18-24 months corrected age
Secondary Outcomes (13)
Language Composite Score
18-24 months CA
Motor Composite Score
18-24 months CA
Weight Gain during the intervention
Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Length gain during the intervention
Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Head circumference gain during the intervention
Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
- +8 more secondary outcomes
Other Outcomes (3)
Milk Type Received
Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Energy and Nutrient Intakes of Infants
Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Maternal Diet During Lactation
Study Day 35±3
Study Arms (3)
Standard fortification
ACTIVE COMPARATORTarget fortification
EXPERIMENTALBUN adjustable fortification
EXPERIMENTALInterventions
Standard fortification assumes that the nutrient content of human milk is constant and involves use of a standard fixed dose of multi-nutrient fortifier and as appropriate nutrient modulars.
Target fortification involves use of a multi-nutrient fortifier as well as weekly analysis of energy and macronutrients of human milk and subsequent addition of fat and protein modulars if needed.
BUN (blood urea nitrogen) adjustable fortification involves use of a multi-nutrient fortifier as well as weekly BUN tests and subsequent addition of a protein modular according to a prescribed algorithm.
Eligibility Criteria
You may qualify if:
- ≤1250 g birth weight or Gestational Age \<30+0 weeks and \<1500 g birth weight.
- Parental/guardian consent to participate.
- Consent for the use of pasteurized donor milk if mother's milk is not available.
You may not qualify if:
- Infant received fortifier or formula before Study Day 1.
- Study Day 1 anticipated to occur after postnatal day 21.
- Infants with congenital or chromosomal anomalies or brain injury that may affect growth or neurodevelopment.
- Enrollment in any other clinical study affecting nutritional management during the feeding intervention.
- Reasonable potential that the infant will be transferred to a NICU where the study protocol will not be continued before they have completed at least 4 weeks of the feeding intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
University of Alberta
Edmonton, Alberta, T6G 2R3, Canada
William Osler Health System-Brampton Civic Hospital
Brampton, Ontario, L6R 3J7, Canada
William Osler Health System-Etobicoke General Hospital
Etobicoke, Ontario, M9V 1R8, Canada
Markham Stouffville Hospital
Markham, Ontario, L3P 7P3, Canada
Trillium Health Partners-Missisauga Hospital
Mississauga, Ontario, L5B 1B8, Canada
Trillium Health Partners-Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9, Canada
North York General Hospital
North York, Ontario, M2K 1E1, Canada
Humber River Hospital
North York, Ontario, M3M 0B2, Canada
Lakeridge Health
Oshawa, Ontario, L1G 2B9, Canada
Mackenzie Health
Richmond Hill, Ontario, L4C 4Z3, Canada
Scarborough Health Network-Centenary Hospital
Scarborough Village, Ontario, M1E 4B9, Canada
Scarborough Health Network-General Hospital
Scarborough Village, Ontario, M1P 2V5, Canada
Michael Garron Hospital
Toronto, Ontario, M4C 3E7, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Unity Health Toronto-St Michaels Hospital
Toronto, Ontario, M5B 1W8, Canada
Sinai Health System-Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
University of Toronto
Toronto, Ontario, M5S 1A1, Canada
Unity Health Toronto-St Josephs Health Centre
Toronto, Ontario, M6R 1B5, Canada
Related Publications (1)
Beggs MR, Pichardo D, Chrzaniecki A, Kotsopoulos K, Bishara R, Ng E, Tomlinson C, Campbell D, Vaz S, Kiss A, Unger S, O'Connor DL. MaxiMoM InForM: individualised fortification of human milk for very low birthweight infants- protocol of a three-arm randomised clinical trial. BMJ Open. 2025 Oct 5;15(10):e105609. doi: 10.1136/bmjopen-2025-105609.
PMID: 41047263DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah O'Connor, PhD RD
The Hospital for Sick Children
- PRINCIPAL INVESTIGATOR
Sharon Unger, MD
Sinai Health System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Associate Scientist
Study Record Dates
First Submitted
November 10, 2021
First Posted
April 1, 2022
Study Start
November 11, 2021
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
July 31, 2025
Record last verified: 2025-07