Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants
NCT ID: NCT00659243
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
32 participants
INTERVENTIONAL
2008-03-31
2010-02-28
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 pasteurized breast milk; one week treatment
Placebo
Placebo
One week treatment
Interventions
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rhBSSL
0.15 g/L rhBSSL added to pasteurized breast milk; 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 pasteurized breast milk
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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Hopital de la Croix Rousse
Lyon, , France
Hopital la Conception,
Marseille, , France
Maternité A. Pinard, Néonatologie
Nancy, , France
Hopital Saint Vincent de Paul
Paris, , France
Hopital des Enfants
Toulouse, , France
CHRU de Tours, Centre de Pédiatrie Gatien de Clocheville
Tours, , France
Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M. Lancisi-G.Salesi"
Ancona, , Italy
Policlinico Universitario-Azienda Ospedeliero di Padova, Dipartimento di Pediatria
Padua, , 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-021
Identifier Type: -
Identifier Source: org_study_id
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