Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)

Last updated: June 11, 2025
Sponsor: The Hospital for Sick Children
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

BUN adjustable fortification

Standard fortification

Target fortification

Clinical Study ID

NCT05308134
1861
  • Ages < 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≤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.

Exclusion

Exclusion Criteria:

  • Infant received fortifier or formula before Study Day 1.

  • Study Day 1 to occur after postnatal day 21.

  • Infants with congenital or chromosomal anomalies or brain injury that may affectgrowth or neurodevelopment.

  • Enrollment in any other clinical study affecting nutritional management during thefeeding intervention.

  • Reasonable potential that the infant will be transferred to a NICU where the studyprotocol will not be continued before they have completed at least 4 weeks of thefeeding intervention.

Study Design

Total Participants: 615
Treatment Group(s): 3
Primary Treatment: BUN adjustable fortification
Phase:
Study Start date:
November 11, 2021
Estimated Completion Date:
July 01, 2026

Study 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).

Connect with a study center

  • University of Alberta

    Edmonton, Alberta T6G 2R3
    Canada

    Site Not Available

  • William Osler Health System-Brampton Civic Hospital

    Brampton, Ontario L6R 3J7
    Canada

    Site Not Available

  • William Osler Health System-Etobicoke General Hospital

    Etobicoke, Ontario M9V 1R8
    Canada

    Site Not Available

  • Markham Stouffville Hospital

    Markham, Ontario L3P 7P3
    Canada

    Site Not Available

  • Trillium Health Partners-Credit Valley Hospital

    Mississauga, Ontario L5M 2N1
    Canada

    Site Not Available

  • Trillium Health Partners-Missisauga Hospital

    Mississauga, Ontario L5B 1B8
    Canada

    Site Not Available

  • Southlake Regional Health Centre

    Newmarket, Ontario L3Y 2P9
    Canada

    Site Not Available

  • Humber River Hospital

    North York, Ontario M3M 0B2
    Canada

    Site Not Available

  • North York General Hospital

    North York, Ontario M2K 1E1
    Canada

    Site Not Available

  • Lakeridge Health

    Oshawa, Ontario L1G 2B9
    Canada

    Site Not Available

  • Mackenzie Health

    Richmond Hill, Ontario L4C 4Z3
    Canada

    Site Not Available

  • Scarborough Health Network-Centenary Hospital

    Scarborough, Ontario M1E 4B9
    Canada

    Site Not Available

  • Scarborough Health Network-General Hospital

    Scarborough, Ontario M1P 2V5
    Canada

    Site Not Available

  • Michael Garron Hospital

    Toronto, Ontario M4C 3E7
    Canada

    Site Not Available

  • Sinai Health System-Mount Sinai Hospital

    Toronto, Ontario M5G 1X5
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Unity Health Toronto-St Josephs Health Centre

    Toronto, Ontario M6R 1B5
    Canada

    Site Not Available

  • Unity Health Toronto-St Michaels Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • University of Toronto

    Toronto, Ontario M5S 1A1
    Canada

    Site Not Available

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