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Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants

This study has been completed.
Sponsor:
Information provided by:
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT00658905
First received: April 14, 2008
Last updated: August 4, 2009
Last verified: August 2009
History of Changes

April 14, 2008
August 4, 2009
April 2008
May 2009   (final data collection date for primary outcome measure)
Coefficient of Fat Absorption in stool [ Time Frame: Stool collected for a 72-hour period during the final 3 days of each treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00658905 on ClinicalTrials.gov Archive Site
Change in length and body weight between the start and end of each treatment period [ Time Frame: Baseline and after one week of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Infant Formula Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.

In this double-blind crossover study, patients will be randomized to receive infant formula including BSSL or infant formula 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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Replacement Therapy in Preterm Infants
  • Drug: BSSL
    0.15 g/L rhBSSL added to infant formula; one week treatment
    Other Name: bucelipase alfa (INN)
  • Drug: Placebo
    One week treatment
  • Active Comparator: 1
    Intervention: Drug: BSSL
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Preterm infants
  • less than or equal to 32 weeks of gestational age
  • appropriate for gestational age
  • enterally fed with infant formula
Both
up to 32 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00658905
BVT.BSSL-020
Yes
Maria Öhman, Biovitrum
Swedish Orphan Biovitrum
Not Provided
Study Director: Kristina Timdahl, MD Biovitrum AB
Swedish Orphan Biovitrum
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP