Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)

The Hospital for Sick Children

Status: Enrolling

Conditions: Very Low Birth Weight Infant

Treatments: Other: Target fortification; Other: BUN adjustable fortification; Other: Standard fortification

Study type: Interventional

Funder types: Other

Identifiers

NCT05308134

1861

Details and patient eligibility

About

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.

Enrollment: 615 estimated patients

Sex: All

Ages: Under 21 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≤1250 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 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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615 participants in 3 patient groups

Standard fortification

Active Comparator group

Treatment:

Other: Standard fortification

Target fortification

Experimental group

Treatment:

Other: Target fortification

BUN adjustable fortification

Experimental group

Treatment:

Other: BUN adjustable fortification