Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
NCT ID: NCT00658905
Last Updated: 2014-11-03
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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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2008-04-30
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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rhBSSL
rhBSSL
0.15 g/L rhBSSL added to infant formula; one week treatment
Placebo
Placebo
One week treatment
Interventions
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rhBSSL
0.15 g/L rhBSSL added to infant formula; one week treatment
Placebo
One week treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* less than or equal to 32 weeks of gestational age
* appropriate for gestational age
* enterally fed with infant formula
32 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
Biovitrum AB
Locations
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Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M.Lancisi -G.Salesi
Ancona, , Italy
Azienda Ospedaliera "Ospedale Policlinico Consorziale",U.O Neonatologia e Terapia Intensiva Neonatale
Bari, , Italy
3) U.O. di Neonatologia e Terapia Intensiva Neonatale Università degli Studi di Milano, Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena-Fondazione IRCCS
Milan, , Italy
4) Policlinico Universitario-Azienda Ospedaliera di Padova, Dipartimento di Pediatria
Padua, , Italy
Clinical Pediatrica-Neonatologia, Policlinico Gemelli, Universita Cattolica
Rome, , Italy
U.O. Neonatologia, Patologia Neonatale e Terapia Intensiva
Rome, , Italy
Countries
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References
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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.
Other Identifiers
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BVT.BSSL-020
Identifier Type: -
Identifier Source: org_study_id
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