NCT00658905
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- rhBSSL
- Conditions
- Replacement Therapy in Preterm Infants
- Sponsor
- Swedish Orphan Biovitrum
- Enrollment
- 33
- Locations
- 6
- Primary Endpoint
- Coefficient of Fat Absorption in stool
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Preterm infants
- •less than or equal to 32 weeks of gestational age
- •appropriate for gestational age
- •enterally fed with infant formula
Exclusion Criteria
- Not provided
Arms & Interventions
rhBSSL
Intervention: rhBSSL
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Coefficient of Fat Absorption in stool
Time Frame: Stool collected for a 72-hour period during the final 3 days of each treatment period
Secondary Outcomes
- Change in length and body weight between the start and end of each treatment period(Baseline and after one week of treatment)
Study Sites (6)
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