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NCT Number: NCT05308134

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Very Low Birth Weight Infant

Age range

Up to 21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

  • 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.

Treatment and study plan

Standard fortification

Other

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

Other

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 fortification

Other

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.

Primary outcomes

  1. Cognitive Composite Score

    Time frame: 18-24 months corrected age

    Bayley Scales of Infant and Toddler Development

Secondary outcomes

  1. Language Composite Score

    Time frame: 18-24 months CA

    Bayley Scales of Infant and Toddler Development

  2. Motor Composite Score

    Time frame: 18-24 months CA

    Bayley Scales of Infant and Toddler Development

  3. Weight Gain during the intervention

    Time frame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first

    Change in z-score

  4. Length gain during the intervention

    Time frame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first

    Change in z-score

  5. Head circumference gain during the intervention

    Time frame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first

    Change in z-score

  6. Body composition at the end of the intervention

    Time frame: 36 weeks corrected age

    Skinfolds

  7. Serious Morbidity

    Time frame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first

    Composite of death, NEC, late onset sepsis, chronic lung disease or severe retinopathy of prematurity (ROP)

  8. Health Economics

    Time frame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first

    Total cost incurred for in-hospital care

  9. Weight at follow-up

    Time frame: 4 months corrected age

    z score

  10. Length at follow-up

    Time frame: 4 months corrected age

    z score

  11. Head Circumference at follow-up

    Time frame: 4 months corrected age

    z score

  12. Body composition at follow-up (approximated)

    Time frame: 4 months corrected age

    Skinfolds

  13. Body composition at follow-up (direct measurement)

    Time frame: 4 months corrected age

    Air displacement plethysmography

Other outcomes

  1. Milk Type Received

    Time frame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first

    Type of milk consumed (i.e. parent, donor)

  2. Energy and Nutrient Intakes of Infants

    Time frame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first

    Energy in kilocalories and nutrient intakes (i.e. macronutrients and micronutrients)

  3. Maternal Diet During Lactation

    Time frame: Study Day 35±3

    Data on maternal diet during the first month of the intervention using the Canadian Diet History Questionnaire II

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

MaxiMoM: Individualized Fortification of Human Milk for Infants Born ≤ 1250 g; a Three Arm Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2022
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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