Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM) (NCT05308134)
MaxiMoM: Individualized Fortification of Human Milk for Infants Born ≤ 1250 g; a Three Arm Randomized Clinical Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alberta — Edmonton, Alberta
Age range: Not specified to 21 Days
🧪 Interventions in This Study
- Standard fortification (OTHER)
- Target fortification (OTHER)
- BUN adjustable fortification (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- University of Alberta — Edmonton, Alberta
- William Osler Health System-Brampton Civic Hospital — Brampton, Ontario
- William Osler Health System-Etobicoke General Hospital — Etobicoke, Ontario
- Markham Stouffville Hospital — Markham, Ontario
- Trillium Health Partners-Missisauga Hospital — Mississauga, Ontario
- Trillium Health Partners-Credit Valley Hospital — Mississauga, Ontario
- Southlake Regional Health Centre — Newmarket, Ontario
- North York General Hospital — North York, Ontario
- Humber River Hospital — North York, Ontario
- Lakeridge Health — Oshawa, Ontario
- Mackenzie Health — Richmond Hill, Ontario
- Scarborough Health Network-Centenary Hospital — Scarborough Village, Ontario
- Scarborough Health Network-General Hospital — Scarborough Village, Ontario
- Michael Garron Hospital — Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario
- Unity Health Toronto-St Michaels Hospital — Toronto, Ontario
- Sinai Health System-Mount Sinai Hospital — Toronto, Ontario
- The Hospital for Sick Children — Toronto, Ontario
- University of Toronto — Toronto, Ontario
- Unity Health Toronto-St Josephs Health Centre — Toronto, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.