Umeå universitets logga

umu.sePublikationer
Ändra sökning
RefereraExporteraLänk till posten
Permanent länk

Direktlänk
Referera
Referensformat
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Annat format
Fler format
Språk
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Annat språk
Fler språk
Utmatningsformat
  • html
  • text
  • asciidoc
  • rtf
Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding: A Randomized Phase 3 Study
Visa övriga samt affilieringar
2016 (Engelska)Ingår i: PLOS ONE, E-ISSN 1932-6203, Vol. 11, nr 5, artikel-id e0156071Artikel i tidskrift (Refereegranskat) Published
Resurstyp
Text
Abstract [en]

Introduction Feeding strategies are critical for healthy growth in preterm infants. Bile salt-stimulated lipase (BSSL), present in human milk, is important for fat digestion and absorption but is inactivated during pasteurization and absent in formula. This study evaluated if recombinant human BSSL (rhBSSL) improves growth in preterm infants when added to formula or pasteurized breast milk. Patients and Methods LAIF (Lipase Added to Infant Feeding) was a randomized, double-blind, placebo-controlled phase 3 study in infants born before 32 weeks of gestation. The primary efficacy variable was growth velocity (g/kg/day) during 4 weeks intervention. Follow-up visits were at 3 and 12 months. The study was performed at 54 centers in 10 European countries. Results In total 415 patients were randomized (rhBSSL n = 207, placebo n = 208), 410 patients were analyzed (rhBSSL n = 206, placebo n = 204) and 365 patients were followed until 12 months. Overall, there was no significantly improved growth velocity during rhBSSL treatment compared to placebo (16.77 vs. 16.56 g/kg/day, estimated difference 0.21 g/kg/day, 95% CI [-0.40; 0.83]), nor were secondary endpoints met. However, in a predefined subgroup, small for gestational age infants, there was a significant effect on growth in favor of rhBSSL during treatment. The incidence of adverse events was higher in the rhBSSL group during treatment. Conclusions Although this study did not meet its primary endpoint, except in a subgroup of infants small for gestational age, and there was an imbalance in short-term safety, these data provide insights in nutrition, growth and development in preterm infants.

Ort, förlag, år, upplaga, sidor
2016. Vol. 11, nr 5, artikel-id e0156071
Nationell ämneskategori
Pediatrik
Identifikatorer
URN: urn:nbn:se:umu:diva-123069DOI: 10.1371/journal.pone.0156071ISI: 000377146100014PubMedID: 27244221Scopus ID: 2-s2.0-84971596930OAI: oai:DiVA.org:umu-123069DiVA, id: diva2:945322
Tillgänglig från: 2016-07-01 Skapad: 2016-06-27 Senast uppdaterad: 2023-03-24Bibliografiskt granskad

Open Access i DiVA

fulltext(491 kB)211 nedladdningar
Filinformation
Filnamn FULLTEXT01.pdfFilstorlek 491 kBChecksumma SHA-512
300779d9a43133996f649de7fb3e0807bd97cd558ad1475f41944b45b72a758d05aee7f7728bfeacffc7702f3dcae4ddcbf4e449f354e8fb9875cb5735d42488
Typ fulltextMimetyp application/pdf

Övriga länkar

Förlagets fulltextPubMedScopus

Person

Hernell, Olle

Sök vidare i DiVA

Av författaren/redaktören
Hernell, Olle
Av organisationen
Pediatrik
I samma tidskrift
PLOS ONE
Pediatrik

Sök vidare utanför DiVA

GoogleGoogle Scholar
Totalt: 211 nedladdningar
Antalet nedladdningar är summan av nedladdningar för alla fulltexter. Det kan inkludera t.ex tidigare versioner som nu inte längre är tillgängliga.

doi
pubmed
urn-nbn

Altmetricpoäng

doi
pubmed
urn-nbn
Totalt: 357 träffar
RefereraExporteraLänk till posten
Permanent länk

Direktlänk
Referera
Referensformat
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Annat format
Fler format
Språk
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Annat språk
Fler språk
Utmatningsformat
  • html
  • text
  • asciidoc
  • rtf