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

  • STATUS
    Recruiting
  • End date
    Jul 1, 2026
  • participants needed
    615
  • sponsor
    The Hospital for Sick Children
Updated on 19 April 2022

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 36 weeks gestational age or hospital discharge whichever occurs first. 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 and processing speed by electroencephalography on a subset of infants. Neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development, at 18-24 months CA.

Details
Condition Very Low Birth Weight Infant
Treatment Target Fortification, Standard fortification, BUN adjustable fortification
Clinical Study IdentifierNCT05308134
SponsorThe Hospital for Sick Children
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

≤1250 g birth weight
Parental/guardian consent to participate
Consent for the use of pasteurized donor milk if mother's milk is not available

Exclusion Criteria

Infant received fortifier or formula before Study Day 1
Study Day 1 to occur after day 21 of life
Infants with congenital or chromosomal anomalies that may affect growth outcome
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
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