Actively Recruiting
Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
Led by The Hospital for Sick Children · Updated on 2025-07-31
615
Participants Needed
20
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born weighing 1250 grams or less, or born before 30 weeks gestation and weighing less than 1500 grams
- Parent or guardian has given consent for participation
- Consent provided for use of pasteurized donor milk if mother's milk is unavailable
You will not qualify if you...
- Infant has received fortifier or formula before the first day of the study
- Study start is expected after 21 days post birth
- Infant has congenital or chromosomal anomalies or brain injury affecting growth or neurodevelopment
- Enrollment in another clinical study affecting nutritional management during feeding intervention
- Infant likely to be transferred to a NICU where study protocol cannot continue before completing at least 4 weeks of feeding intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Active, Not Recruiting
2
William Osler Health System-Brampton Civic Hospital
Brampton, Ontario, Canada, L6R 3J7
Active, Not Recruiting
3
William Osler Health System-Etobicoke General Hospital
Etobicoke, Ontario, Canada, M9V 1R8
Active, Not Recruiting
4
Markham Stouffville Hospital
Markham, Ontario, Canada, L3P 7P3
Active, Not Recruiting
5
Trillium Health Partners-Missisauga Hospital
Mississauga, Ontario, Canada, L5B 1B8
Active, Not Recruiting
6
Trillium Health Partners-Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Active, Not Recruiting
7
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Active, Not Recruiting
8
North York General Hospital
North York, Ontario, Canada, M2K 1E1
Active, Not Recruiting
9
Humber River Hospital
North York, Ontario, Canada, M3M 0B2
Active, Not Recruiting
10
Lakeridge Health
Oshawa, Ontario, Canada, L1G 2B9
Active, Not Recruiting
11
Mackenzie Health
Richmond Hill, Ontario, Canada, L4C 4Z3
Active, Not Recruiting
12
Scarborough Health Network-Centenary Hospital
Scarborough Village, Ontario, Canada, M1E 4B9
Active, Not Recruiting
13
Scarborough Health Network-General Hospital
Scarborough Village, Ontario, Canada, M1P 2V5
Active, Not Recruiting
14
Michael Garron Hospital
Toronto, Ontario, Canada, M4C 3E7
Active, Not Recruiting
15
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
16
Unity Health Toronto-St Michaels Hospital
Toronto, Ontario, Canada, M5B 1W8
Active, Not Recruiting
17
Sinai Health System-Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
18
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Active, Not Recruiting
19
University of Toronto
Toronto, Ontario, Canada, M5S 1A1
Active, Not Recruiting
20
Unity Health Toronto-St Josephs Health Centre
Toronto, Ontario, Canada, M6R 1B5
Active, Not Recruiting
Research Team
D
Deborah O'Connor, PhD RD
CONTACT
S
Sharon Unger, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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