Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants
NCT ID: NCT01413581
Last Updated: 2015-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
415 participants
INTERVENTIONAL
2011-05-31
2014-08-31
Brief Summary
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Detailed Description
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The study drug, rhBSSL or placebo, will be administered during a 4 week treatment period by adding it to either infant formula or pasteurized breast milk.
The study will also evaluate the safety and tolerability of rhBSSL.
Eligible patients will be randomized in a ratio of 1:1 (rhBSSL:placebo). The study consists of maximum 1 week screening period, a 4-week treatment period and a 2 year follow-up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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rhBSSL
rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.
Placebo
Placebo
Placebo
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
Interventions
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rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.
Placebo
Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
Eligibility Criteria
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Inclusion Criteria
* Preterm infant who is less than 33 weeks postmenstrual age at the time of randomization.
* Preterm infant who is appropriate for gestational age (AGA) or small for gestational age (SGA) at birth.
* Preterm infant who is receiving food enterally (bottle or gavage tube) at a level of at least 100 ml/kg/day at randomization.
* Preterm infant whose enteral feeding consists of only infant formula or only pasteurized breast milk at the time of inclusion, and who are expected to remain on only infant formula for 4 weeks, or only pasteurized breast milk for at least 2 weeks following treatment initiation.
* Preterm infant who is expected not to receive any fresh breast milk for 4 weeks following treatment initiation.
* Informed consent is obtained.
Exclusion Criteria
* Criteria to ensure no disease or treatment affecting growth or development, e.g. brain disease, necrotizing enterocolitis.
* Enrolled in another concurrent clinical intervention study.
10 Weeks
ALL
No
Sponsors
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Swedish Orphan Biovitrum
INDUSTRY
Responsible Party
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Principal Investigators
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Kristina Timdahl, MD
Role: STUDY_DIRECTOR
Swedish Orphan Biovitrum
Locations
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Swedish Orphan Biovitrum Investigational Site
Bruges, , Belgium
Swedish Orphan Biovitrum Investigational Site
Leuven, , Belgium
Swedish Orphan Biovitrum Investigational Site
Liège, , Belgium
Swedish Orphan Biovitrum Investigational Site
Rocourt, , Belgium
Swedish Orphan Biovitrum Investigational Site
Wilrijk, , Belgium
Swedish Orphan Biovitrum Investigational Site
Hradec Králové, , Czechia
Swedish Orphan Biovitrum Investigational Site
Olomouc, , Czechia
Swedish Orphan Biovitrum Investigational Site
Prague, , Czechia
Swedish Orphan Biovitrum Investigational Site
Zlín, , Czechia
Swedish Orphan Biovitrum Investigational Site
Amiens, , France
Swedish Orphan Biovitrum Investigational Site
Lille, , France
Swedish Orphan Biovitrum Investigational Site
Nancy, , France
Swedish Orphan Biovitrum Investigational Site
Paris, , France
Swedish Orphan Biovitrum Investigational Site
Rouen, , France
Swedish Orphan Biovitrum Investigational Site
Strasbourg, , France
Swedish Orphan Biovitrum Investigational Site
Toulouse, , France
Swedish Orphan Biovitrum Investigational Site
Berlin, , Germany
Swedish Orphan Biovitrum Investigational Site
Freiburg im Breisgau, , Germany
Swedish Orphan Biovitrum Investigational Site
Heidelberg, , Germany
Swedish Orphan Biovitrum Investigational Site
Wiesbaden, , Germany
Swedish Orphan Biovitrum Investigational Site
Budapest, , Hungary
Swedish Orphan Biovitrum Investigational Site
Gyula, , Hungary
Swedish Orphan Biovitrum Investigational Site
Miskolc, , Hungary
Swedish Orphan Biovitrum Investigational Site
Nyíregyháza, , Hungary
Swedish Orphan Biovitrum Investigational Site
Pécs, , Hungary
Swedish Orphan Biovitrum Investigational Site
Veszprém, , Hungary
Swedish Orphan Biovitrum Investigational Site
Ancona, , Italy
Swedish Orphan Biovitrum Investigational Site
Bari, , Italy
Swedish Orphan Biovitrum Investigational Site
Foggia, , Italy
Swedish Orphan Biovitrum Investigational Site
Milan, , Italy
Swedish Orphan Biovitrum Investigational Site
Padua, , Italy
Swedish Orphan Biovitrum Investigational Site
Roma, , Italy
Swedish Orphan Biovitrum Investigational Site
Bydgoszcz, , Poland
Swedish Orphan Biovitrum Investigational Site
Gdansk, , Poland
Swedish Orphan Biovitrum Investigational Site
Lodz, , Poland
Swedish Orphan Biovitrum Investigational Site
Poznan, , Poland
Swedish Orphan Biovitrum Investigational Site
Warsaw, , Poland
Swedish Orphan Biovitrum Investigational Site
Ivanovo, , Russia
Swedish Orphan Biovitrum Investigational Site
Nizhny Novgorod, , Russia
Swedish Orphan Biovitrum Investigational Site
Almería, , Spain
Swedish Orphan Biovitrum Investigational Site
Cadiz, , Spain
Swedish Orphan Biovitrum Investigational Site
Córdoba, , Spain
Swedish Orphan Biovitrum Investigational Site
Madrid, , Spain
Swedish Orphan Biovitrum Investigational Site
Málaga, , Spain
Swedish Orphan Biovitrum Investigational Site
Oviedo, , Spain
Swedish Orphan Biovitrum Investigational Site
Salamanca, , Spain
Swedish Orphan Biovitrum Investigational Site
Santiago de Compostela, , Spain
Swedish Orphan Biovitrum Investigational Site
Stockholm, , Sweden
Swedish Orphan Biovitrum Investigational Site
Umeå, , Sweden
Countries
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References
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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.
Related Links
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Results are available on the European Union Clinical Trials Register
Other Identifiers
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BVT.BSSL-030
Identifier Type: -
Identifier Source: org_study_id
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