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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.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>This randomized controlled trial will recruit preterm infants (\u2264\u200932\u2009weeks of gestation) within the first 7\u2009days of life. After reaching 80\u2009ml\/kg\/day of enteral feeding, patients will be randomized to receive standard fortification (HMF, Nutricia) or targeted fortification (modular components: Bebilon Bialka, Nutricia\u2014protein; Polycal, Nutricia\u2014carbohydrates; Calogen, Nutricia\u2014lipids). The intervention will continue until 37\u2009weeks 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\u2009weeks post-conceptional age or discharge. Secondary outcomes include neurodevelopment at 12\u2009months assessed with Bayley Scale of Development III, repeated at 36\u2009months; body composition at discharge and at 4\u2009months; and incidence of necrotizing enterocolitis, sepsis, retinopathy of prematurity, and bronchopulmonary dysplasia.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Discussion<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03775785\">NCT03775785<\/jats:ext-link>, Registered on July 2019.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s13063-020-04841-x","type":"journal-article","created":{"date-parts":[[2020,11,23]],"date-time":"2020-11-23T11:04:15Z","timestamp":1606129455000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Effect of targeted vs standard fortification of breast milk on growth and development of preterm infants (\u2264\u200932\u2009weeks): study protocol for a randomized controlled trial"],"prefix":"10.1186","volume":"21","author":[{"given":"Joanna","family":"Seliga-Siwecka","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Chmielewska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katarzyna","family":"Jasi\u0144ska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,11,23]]},"reference":[{"key":"4841_CR1","unstructured":"Howson CP KM, Lawn JE, editors. 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It is registered at  (NCT03775785). Results will be submitted to peer-reviewed journals (neonatology, paediatrics, and nutrition). Abstracts will be submitted to relevant national and international conferences.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"We do not plan to enclose any patient data requiring separate consent for publication.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"JS-S and AC received research grants from the Nutricia Research Foundation for the conduct of the current trial as well as other trials. The remaining authors declare that they have no competing financial or non-financial interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"946"}}