Back to resultsEfficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants
Primary Purpose
Replacement Therapy in Preterm Infants
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rhBSSL
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Replacement Therapy in Preterm Infants focused on measuring Replacement therapy, Pasteurized breast milk, Preterm infants, BSSL
Eligibility Criteria
Inclusion Criteria:
- Preterm infants
- less than or equal to 32 weeks of gestational age
- appropriate for gestational age
- enterally fed with pasteurized breast milk
Sites / Locations
- Hopital de la Croix Rousse
- Hopital la Conception,
- Maternité A. Pinard, Néonatologie
- Hopital Saint Vincent de Paul
- Hopital des Enfants
- CHRU de Tours, Centre de Pédiatrie Gatien de Clocheville
- Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M. Lancisi-G.Salesi"
- Policlinico Universitario-Azienda Ospedeliero di Padova, Dipartimento di Pediatria
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
rhBSSL
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Coefficient of Fat Absorption measured in stool
Secondary Outcome Measures
Change in length and body weight
Full Information
NCT ID
NCT00659243
First Posted
April 14, 2008
Last Updated
October 31, 2014
Sponsor
Swedish Orphan Biovitrum
1. Study Identification
Unique Protocol Identification Number
NCT00659243
Brief Title
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants
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 Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Orphan Biovitrum
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Replacement Therapy in Preterm Infants
Keywords
Replacement therapy, Pasteurized breast milk, Preterm infants, BSSL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rhBSSL
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
rhBSSL
Other Intervention Name(s)
bucelipase alfa (INN)
Intervention Description
0.15 g/L rhBSSL added to pasteurized breast milk; one week treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One week treatment
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in length and body weight
Time Frame
Baseline and after one week of treatment
10. Eligibility
Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preterm infants
less than or equal to 32 weeks of gestational age
appropriate for gestational age
enterally fed with pasteurized breast milk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Timdahl, MD
Organizational Affiliation
Biovitrum AB
Official's Role
Study Director
Facility Information:
Facility Name
Hopital de la Croix Rousse
City
Lyon
Country
France
Facility Name
Hopital la Conception,
City
Marseille
Country
France
Facility Name
Maternité A. Pinard, Néonatologie
City
Nancy
Country
France
Facility Name
Hopital Saint Vincent de Paul
City
Paris
Country
France
Facility Name
Hopital des Enfants
City
Toulouse
Country
France
Facility Name
CHRU de Tours, Centre de Pédiatrie Gatien de Clocheville
City
Tours
Country
France
Facility Name
Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M. Lancisi-G.Salesi"
City
Ancona
Country
Italy
Facility Name
Policlinico Universitario-Azienda Ospedeliero di Padova, Dipartimento di Pediatria
City
Padova
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
25222806
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants
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