MaxiMoM: Individualized Fortification of Human Milk for Infants Born ≤ 1250 g; a Three Arm Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 615
- Locations
- 40
- Primary Endpoint
- Cognitive Composite Score
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 21 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Study Day 1 anticipated to occur after postnatal day
- •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.
Arms & Interventions
Standard fortification
Intervention: Standard fortification (Other)
Target fortification
Intervention: Target fortification (Other)
BUN adjustable fortification
Intervention: BUN adjustable fortification (Other)
Outcomes
Primary Outcomes
Cognitive Composite Score
Time Frame: 18-24 months corrected age
Bayley Scales of Infant and Toddler Development
Secondary Outcomes
- Language Composite Score(18-24 months CA)
- Motor Composite Score(18-24 months CA)
- Weight Gain during the intervention(Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first)
- Length gain during the intervention(Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first)
- Head circumference gain during the intervention(Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first)
- Body composition at the end of the intervention(36 weeks corrected age)
- Serious Morbidity(Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first)
- Health Economics(Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first)
- Weight at follow-up(4 months corrected age)
- Length at follow-up(4 months corrected age)
- Head Circumference at follow-up(4 months corrected age)
- Body composition at follow-up (approximated)(4 months corrected age)
- Body composition at follow-up (direct measurement)(4 months corrected age)
Investigators
Deborah O'Connor
Senior Associate Scientist
The Hospital for Sick Children