Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
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- STATUS
- Recruiting
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- End date
- Jul 1, 2026
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- participants needed
- 615
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- sponsor
- The Hospital for Sick Children
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.
Details
| Condition | Very Low Birth Weight Infant |
|---|---|
| Treatment | Target Fortification, Standard fortification, BUN adjustable fortification |
| Clinical Study Identifier | NCT05308134 |
| Sponsor | The Hospital for Sick Children |
| Last Modified on | 19 April 2022 |
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