Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
- Conditions
- Very Low Birth Weight Infant
- 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 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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 615
- ≤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.
- Infant received fortifier or formula before Study Day 1.
- Study Day 1 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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 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
Weight Gain during the intervention Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first Change in z-score
Length gain during the intervention Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first Change in z-score
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
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)
Health Economics Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first Total cost incurred for in-hospital care
Weight at follow-up 4 months corrected age z score
Length at follow-up 4 months corrected age z score
Head Circumference at follow-up 4 months corrected age z score
Body composition at follow-up (approximated) 4 months corrected age Skinfolds
Body composition at follow-up (direct measurement) 4 months corrected age Air displacement plethysmography
Trial Locations
- Locations (20)
University of Alberta
🇨🇦Edmonton, Alberta, Canada
William Osler Health System-Brampton Civic Hospital
🇨🇦Brampton, Ontario, Canada
William Osler Health System-Etobicoke General Hospital
🇨🇦Etobicoke, Ontario, Canada
Markham Stouffville Hospital
🇨🇦Markham, Ontario, Canada
Trillium Health Partners-Missisauga Hospital
🇨🇦Mississauga, Ontario, Canada
Trillium Health Partners-Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
North York General Hospital
🇨🇦North York, Ontario, Canada
Humber River Hospital
🇨🇦North York, Ontario, Canada
Lakeridge Health
🇨🇦Oshawa, Ontario, Canada
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