NCT00658905CompletedPhase 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
Swedish Orphan Biovitrum6 sites in 1 country33 target enrollmentStarted: April 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Locations
- 6
- Primary Endpoint
- Coefficient of Fat Absorption in stool
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 32 Weeks (Child)
- Sex
- 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 infant formula
Exclusion Criteria
- Not provided
Arms & Interventions
rhBSSL
Active Comparator
Intervention: rhBSSL (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
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)
Investigators
Study Sites (6)
Loading locations...
Similar Trials
Completed
Phase 2
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm InfantsReplacement Therapy in Preterm InfantsNCT00659243Swedish Orphan Biovitrum32
Terminated
Phase 2
Blepharospasm Short IntervalBlepharospasmNCT00507637Merz Pharmaceuticals GmbH8
Completed
Phase 2
Mid and Standard Frequency Ventilation in Infants With Respiratory Distress SyndromeVentilator-Induced Lung InjuryRespiratory Distress SyndromePreterm InfantBronchopulmonary DysplasiaNCT03231735University of Alabama at Birmingham60
Completed
Not Applicable
A Study of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic DermatitisHealthyNCT04662619Johnson & Johnson Consumer Inc. (J&JCI)273
Completed
Phase 4
Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline ContourContourNCT03425253Allergan58