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Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00659243
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : November 3, 2014
Information provided by (Responsible Party):
Swedish Orphan Biovitrum

Brief Summary:
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.

Condition or disease Intervention/treatment Phase
Replacement Therapy in Preterm Infants Drug: rhBSSL Drug: Placebo Phase 2

Detailed Description:
In this double-blind crossover study, patients will be randomized to receive pasteurized breast milk including BSSL or pasteurized breast milk without BSSL for the first 7 days. After a wash-out period of 2 days the patients will "crossover" to the other treatment regimen and receive an additional 7 days treatment. The primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Pasteurized Breast Milk Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age
Study Start Date : March 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: rhBSSL Drug: rhBSSL
0.15 g/L rhBSSL added to pasteurized breast milk; one week treatment
Other Name: bucelipase alfa (INN)

Placebo Comparator: Placebo Drug: Placebo
One week treatment

Primary Outcome Measures :
  1. Coefficient of Fat Absorption measured in stool [ Time Frame: Stool collected for a 72-hour period during the final 3 days of each treatment period ]

Secondary Outcome Measures :
  1. Change in length and body weight [ Time Frame: Baseline and after one week of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Preterm infants
  • less than or equal to 32 weeks of gestational age
  • appropriate for gestational age
  • enterally fed with pasteurized breast milk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00659243

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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
Padova, Italy
Sponsors and Collaborators
Swedish Orphan Biovitrum
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Study Director: Kristina Timdahl, MD Biovitrum AB

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Swedish Orphan Biovitrum Identifier: NCT00659243     History of Changes
Other Study ID Numbers: BVT.BSSL-021
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014
Keywords provided by Swedish Orphan Biovitrum:
Replacement therapy
Pasteurized breast milk
Preterm infants
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications