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Effect of targeted vs standard fortification of breast milk on growth and development of preterm infants (<= 32weeks): study protocol for a randomized controlled trial
Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
2020 (English)In: Trials, E-ISSN 1745-6215, Vol. 21, no 1, article id 946Article in journal (Refereed) Published
Abstract [en]

Background: Human milk is recommended for all very low birth weight infants. Breastmilk is highly variable in nutrient content, failing to meet the nutritional demands of this group. Fortification of human milk is recommended to prevent extrauterine growth retardation and associated poor neurodevelopmental outcome. However, standard fortification with fixed dose multicomponent fortifier does not account for the variability in milk composition. Targeted fortification is a promising alternative and needs further investigation.

Methods: This randomized controlled trial will recruit preterm infants (≤ 32 weeks of gestation) within the first 7 days of life. After reaching 80 ml/kg/day of enteral feeding, patients will be randomized to receive standard fortification (HMF, Nutricia) or targeted fortification (modular components: Bebilon Bialka, Nutricia—protein; Polycal, Nutricia—carbohydrates; Calogen, Nutricia—lipids). The intervention will continue until 37 weeks of post-conception age or hospital discharge. Parents and outcome assessors will be blinded to the intervention. The primary outcome measure is velocity of weight, length, and head growth until 36 weeks post-conceptional age or discharge. Secondary outcomes include neurodevelopment at 12 months assessed with Bayley Scale of Development III, repeated at 36 months; body composition at discharge and at 4 months; and incidence of necrotizing enterocolitis, sepsis, retinopathy of prematurity, and bronchopulmonary dysplasia.

Discussion: Targeted fortification has previously been shown as doable in the neonatal intensive care unit context. If it shows to improve growth and neonatal outcome, choosing the targeted fortification as a first line nutritional approach in very low birth weight infants may become a recommendation.

Trial registration: ClinicalTrials.govNCT03775785, Registered on July 2019.

Place, publisher, year, edition, pages
BioMed Central, 2020. Vol. 21, no 1, article id 946
Keywords [en]
Preterm, Very low birth weight, Enteral nutrition, Breast milk, Fortification, Growth
National Category
Pediatrics
Identifiers
URN: urn:nbn:se:umu:diva-178309DOI: 10.1186/s13063-020-04841-xISI: 000595712600009PubMedID: 33225961Scopus ID: 2-s2.0-85096432123OAI: oai:DiVA.org:umu-178309DiVA, id: diva2:1515872
Available from: 2021-01-11 Created: 2021-01-11 Last updated: 2024-01-17Bibliographically approved

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Chmielewska, Anna

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