drugset / Trial / NCT01413581
Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.
Timeline
- Start
- 2011-05
- Primary completion
- 2013-07
- Completion
- 2014-08
Outcome
Missed primary endpoint
Stopped: “Primary endpoint showed no stat significant difference. FU \> M12 terminated.”
paper Although this study did not meet its primary endpoint, except in a subgroup of infants small for gestational age PMID 27244221 ↗
Publications
- Casper C, Hascoet JM, Ertl T, Gadzinowski JS, Carnielli V, Rigo J, Lapillonne A, Couce ML, Vagero M, Palmgren I, Timdahl K, Hernell O. Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding: A Randomized Phase 3 Study. PLoS One. 2016 May 31;11(5):e0156071. doi: 10.1371/journal.pone.0156071. eCollection 2016.
- Casper C, Carnielli VP, Hascoet JM, Lapillonne A, Maggio L, Timdahl K, Olsson B, Vagero M, Hernell O. rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):61-9. doi: 10.1097/MPG.0000000000000365.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rhBSSL | Protein / enzyme biologic | — | — |