{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T01:16:54Z","timestamp":1791335814099,"version":"4.3.1"},"reference-count":0,"publisher":"S. Karger AG","issue":"2","license":[{"start":{"date-parts":[[2023,12,13]],"date-time":"2023-12-13T00:00:00Z","timestamp":1702425600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2023,12,13]],"date-time":"2023-12-13T00:00:00Z","timestamp":1702425600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Neonatology"],"published-print":{"date-parts":[[2024]]},"abstract":"<b><i>Objective:<\/i><\/b> Uncertainty exists regarding optimal supplemental diet for very preterm infants if the mother\u2019s own milk (MM) is insufficient. We evaluated feasibility for a randomised controlled trial (RCT) powered to detect important differences in health outcomes. <b><i>Methods:<\/i><\/b> In this open, parallel, feasibility trial, we randomised infants 25+0\u201331+6 weeks of gestation by opt-out consent to one of three diets: unfortified human milk (UHM) (unfortified MM and\/or unfortified pasteurised human donor milk (DM) supplement), fortified human milk (FHM) (fortified MM and\/or fortified DM supplement), and unfortified MM and\/or preterm formula (PTF) supplement from birth to 35+0 weeks post menstrual age. Feasibility outcomes included opt-outs, adherence rates, and slow growth safety criteria. We also obtained anthropometry, and magnetic resonance imaging body composition data at term and term plus 6 weeks (opt-in consent). <b><i>Results:<\/i><\/b> Of 35 infants randomised to UHM, 34 to FHM, and 34 to PTF groups, 21, 19, and 24 infants completed imaging at term, respectively. Study entry opt-out rate was 38%; 6% of parents subsequently withdrew from feeding intervention. Two infants met predefined slow weight gain thresholds. There were no significant between-group differences in term total adipose tissue volume (mean [SD]: UHM: 0.870 L [0.35 L]; FHM: 0.889 L [0.31 L]; PTF: 0.809 L [0.25 L], <i>p<\/i> = 0.66), nor in any other body composition measure or anthropometry at either timepoint. <b><i>Conclusions:<\/i><\/b> Randomisation to UHM, FHM, and PTF diets by opt-out consent was acceptable to parents and clinical teams, associated with safe growth profiles and no significant differences in body composition. Our data provide justification to proceed to a larger RCT.<\/jats:p>","DOI":"10.1159\/000535498","type":"journal-article","created":{"date-parts":[[2023,12,13]],"date-time":"2023-12-13T17:00:32Z","timestamp":1702486832000},"page":"222-232","source":"Crossref","is-referenced-by-count":13,"title":["Preterm Formula, Fortified or Unfortified Human Milk for Very Preterm Infants, the PREMFOOD Study: A Parallel Randomised Feasibility Trial"],"prefix":"10.1159","volume":"121","author":[{"given":"Luke","family":"Mills","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karyn E.","family":"Chappell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robby","family":"Emsley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Afshin","family":"Alavi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Izabela","family":"Andrzejewska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shalini","family":"Santhakumaran","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Nicholl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Chang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabita","family":"Uthaya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neena","family":"Modi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2023,12,13]]},"container-title":["Neonatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/neo\/article-pdf\/121\/2\/222\/4188728\/000535498.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/karger.com\/neo\/article-pdf\/121\/2\/222\/4188728\/000535498.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T11:58:04Z","timestamp":1745409484000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000535498"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12,13]]},"references-count":0,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2024,4,2]]},"published-print":{"date-parts":[[2024,3,28]]}},"URL":"https:\/\/doi.org\/10.1159\/000535498","archive":["Portico"],"relation":{"is-supplemented-by":[{"id-type":"doi","id":"10.6084\/m9.figshare.24785829","asserted-by":"subject"}],"has-preprint":[{"id-type":"doi","id":"10.1101\/2023.10.31.23297886","asserted-by":"object"}]},"ISSN":["1661-7800","1661-7819"],"issn-type":[{"value":"1661-7800","type":"print"},{"value":"1661-7819","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,12,13]]}}}