Very Low Birth Weight InfantNCT05308134
Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
A study testing Standard fortification, Target fortification and BUN adjustable fortification in people with Very Low Birth Weight Infant, run by The Hospital for Sick Children at 20 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 days
- Conditions the study is for
- Very Low Birth Weight Infant
- What is being tested?
- Standard fortification, Target fortification and BUN adjustable fortification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 615 participants
- Where
- 20 sitesCanada
- Study dates
- 11 Nov 2021to 1 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≤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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Canada20 sites
William Osler Health System-Brampton Civic Hospital
Brampton, Ontario, L6R 3J7
University of Alberta
Edmonton, Alberta, T6G 2R3
William Osler Health System-Etobicoke General Hospital
Etobicoke, Ontario, M9V 1R8
Markham Stouffville Hospital
Markham, Ontario, L3P 7P3
Trillium Health Partners-Missisauga Hospital
Mississauga, Ontario, L5B 1B8
Trillium Health Partners-Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
North York General Hospital
North York, Ontario, M2K 1E1
Humber River Hospital
North York, Ontario, M3M 0B2
Lakeridge Health
Oshawa, Ontario, L1G 2B9
Mackenzie Health
Richmond Hill, Ontario, L4C 4Z3
Scarborough Health Network-Centenary Hospital
Scarborough Village, Ontario, M1E 4B9
Scarborough Health Network-General Hospital
Scarborough Village, Ontario, M1P 2V5
Michael Garron Hospital
Toronto, Ontario, M4C 3E7
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Unity Health Toronto-St Michaels Hospital
Toronto, Ontario, M5B 1W8
Sinai Health System-Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
University of Toronto
Toronto, Ontario, M5S 1A1
Unity Health Toronto-St Josephs Health Centre
Toronto, Ontario, M6R 1B5
About this study
Official title: MaxiMoM: Individualized Fortification of Human Milk for Infants Born ≤ 1250 g; a Three Arm Randomized Clinical Trial
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.
Read the detailed description
The end of the feeding intervention is defined as: the infant is 36+0 weeks CA, is discharged home, or receives two oral feeds daily for three consecutive days without top-up. The exception to the 36+0 weeks intervention end-date is in the situation where an infant remains hospitalized but has not completed at least four weeks of the feeding intervention (i.e. 4 weeks following Study Day 1).
- Conditions
- Very Low Birth Weight Infant
- Being tested
- Standard fortification, Target fortification, BUN adjustable fortification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard fortificationOther
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 fortificationOther
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 adjustable fortificationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard fortification | Active comparator | Not described Receives: Other: Standard fortification |
| Target fortification | Experimental | Not described Receives: Other: Target fortification |
| BUN adjustable fortification | Experimental | Not described Receives: Other: BUN adjustable fortification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Composite Score
Bayley Scales of Infant and Toddler Development
Measured: 18-24 months corrected age
Secondary outcomes (13)
Language Composite Score
Bayley Scales of Infant and Toddler Development
Measured: 18-24 months CA
Motor Composite Score
Bayley Scales of Infant and Toddler Development
Measured: 18-24 months CA
Weight Gain during the intervention
Change in z-score
Measured: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Length gain during the intervention
Change in z-score
Measured: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Head circumference gain during the intervention
Change in z-score
Measured: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Body composition at the end of the intervention
Skinfolds
Measured: 36 weeks corrected age
Serious Morbidity
Composite of death, NEC, late onset sepsis, chronic lung disease or severe retinopathy of prematurity (ROP)
Measured: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Health Economics
Total cost incurred for in-hospital care
Measured: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Weight at follow-up
z score
Measured: 4 months corrected age
Length at follow-up
z score
Measured: 4 months corrected age
Head Circumference at follow-up
z score
Measured: 4 months corrected age
Body composition at follow-up (approximated)
Skinfolds
Measured: 4 months corrected age
Body composition at follow-up (direct measurement)
Air displacement plethysmography
Measured: 4 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start11 Nov 2021
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 615 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah O'Connor, The Hospital for Sick Children
- Investigators
- Deborah O'Connor, PhD RD, Principal investigator, The Hospital for Sick ChildrenSharon Unger, MD, Principal investigator, Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308134
- Sponsor's protocol ID
- 1861
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2021
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41047263