Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
- Conditions
- Very Low Birth Weight Infant
- Interventions
- Other: Standard fortificationOther: BUN adjustable fortificationOther: Target fortification
- Registration Number
- NCT05308134
- Lead Sponsor
- The Hospital for Sick Children
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 615
- ≤1250 g birth weight.
- Parental/guardian consent to participate.
- Consent for the use of pasteurized donor milk if mother's milk is not available.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard fortification Standard fortification - BUN adjustable fortification BUN adjustable fortification - Target fortification Target fortification -
- Primary Outcome Measures
Name Time Method Cognitive Composite Score 18-24 months corrected age Bayley Scales of Infant and Toddler Development
- Secondary Outcome Measures
Name Time Method Weight Gain during the intervention Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first Change in z-score
Language Composite Score 18-24 months CA Bayley Scales of Infant and Toddler Development
Motor Composite Score 18-24 months CA Bayley Scales of Infant and Toddler Development
Length gain during the intervention Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first Change in z-score
Serious Morbidity 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)
Head circumference gain during the intervention Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first Change in z-score
Body composition at the end of the intervention 36 weeks corrected age Skinfolds
Trial Locations
- Locations (20)
William Osler Health System-Etobicoke General Hospital
🇨🇦Etobicoke, Ontario, Canada
Markham Stouffville Hospital
🇨🇦Markham, Ontario, Canada
Scarborough Health Network-General Hospital
🇨🇦Scarborough, Ontario, Canada
Unity Health Toronto-St Michaels Hospital
🇨🇦Toronto, Ontario, Canada
Lakeridge Health
🇨🇦Oshawa, Ontario, Canada
North York General Hospital
🇨🇦North York, Ontario, Canada
Scarborough Health Network-Centenary Hospital
🇨🇦Scarborough, Ontario, Canada
Sinai Health System-Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Unity Health Toronto-St Josephs Health Centre
🇨🇦Toronto, Ontario, Canada
Humber River Hospital
🇨🇦North York, Ontario, Canada
Mackenzie Health
🇨🇦Richmond Hill, Ontario, Canada
University of Toronto
🇨🇦Toronto, Ontario, Canada
Trillium Health Partners-Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
William Osler Health System-Brampton Civic Hospital
🇨🇦Brampton, Ontario, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Trillium Health Partners-Missisauga Hospital
🇨🇦Mississauga, Ontario, Canada
Michael Garron Hospital
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada