Status:
COMPLETED
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants
Lead Sponsor:
Swedish Orphan Biovitrum
Conditions:
Replacement Therapy in Preterm Infants
Eligibility:
All Genders
Up to 32 years
Phase:
PHASE2
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 perio...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Preterm infants
- less than or equal to 32 weeks of gestational age
- appropriate for gestational age
- enterally fed with pasteurized breast milk
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00659243
Start Date
March 1 2008
End Date
February 1 2010
Last Update
November 3 2014
Active Locations (8)
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1
Hopital de la Croix Rousse
Lyon, France
2
Hopital la Conception,
Marseille, France
3
Maternité A. Pinard, Néonatologie
Nancy, France
4
Hopital Saint Vincent de Paul
Paris, France