Personalized nutrient fortification for very low birth weight infants

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

This study is testing which of three different ways to add nutrients to human milk helps very low birth weight infants grow better and develop more fully.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 615 (estimated)
• Ages: N/A to 21 Days
• Sex: All
• Sponsor: The Hospital for Sick Children (other)
• Locations: 20 sites (Edmonton, Alberta and 19 other locations)
• Trial ID: NCT05308134 on ClinicalTrials.gov

What this trial studies

This study aims to improve the nutritional status, growth, and neurodevelopment of very low birth weight infants by comparing three different methods of fortifying human milk: standard fortification, target fortification, and BUN adjustable fortification. Infants will be randomly assigned to one of these methods until they reach 36 weeks gestational age or are discharged from the hospital. The goal is to determine which fortification method provides the best outcomes for these vulnerable infants. The study will ensure that feedings are prepared in controlled environments to maintain consistency and safety.

Who should consider this trial

Good fit: Ideal candidates for this study are infants born weighing 1250 grams or less who have parental consent to participate.

Not a fit: Patients who may not benefit from this study include those with congenital or chromosomal anomalies affecting growth or those who have received fortifier or formula before the study begins.

Why it matters

Potential benefit: If successful, this study could lead to improved growth and neurodevelopment outcomes for very low birth weight infants.

How similar studies have performed: While individualized fortification methods have been proposed, there is currently insufficient evidence from other studies to support their implementation, making this approach relatively novel.

Eligibility criteria

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.

Where this trial is running

Edmonton, Alberta and 19 other locations

• University of Alberta — Edmonton, Alberta, Canada (ACTIVE_NOT_RECRUITING)
• William Osler Health System-Brampton Civic Hospital — Brampton, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• William Osler Health System-Etobicoke General Hospital — Etobicoke, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Markham Stouffville Hospital — Markham, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Trillium Health Partners-Missisauga Hospital — Mississauga, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Trillium Health Partners-Credit Valley Hospital — Mississauga, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Southlake Regional Health Centre — Newmarket, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• North York General Hospital — North York, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Humber River Hospital — North York, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Lakeridge Health — Oshawa, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Mackenzie Health — Richmond Hill, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Scarborough Health Network-Centenary Hospital — Scarborough Village, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Scarborough Health Network-General Hospital — Scarborough Village, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Michael Garron Hospital — Toronto, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
• Unity Health Toronto-St Michaels Hospital — Toronto, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Sinai Health System-Mount Sinai Hospital — Toronto, Ontario, Canada (RECRUITING)
• The Hospital for Sick Children — Toronto, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• University of Toronto — Toronto, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Unity Health Toronto-St Josephs Health Centre — Toronto, Ontario, Canada (ACTIVE_NOT_RECRUITING)

Study contacts

• Principal investigator: Deborah O'Connor, PhD RD — The Hospital for Sick Children
• Study coordinator: Deborah O'Connor, PhD RD

Conditions: Very Low Birth Weight Infant