NCT01413581

Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants

A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: Swedish Orphan Biovitrum · Industry
• Sex: All
• Age: 10 Weeks
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.

Detailed description

The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo. The infants should be born before week 32 of gestational age. The study drug, rhBSSL or placebo, will be administered during a 4 week treatment period by adding it to either infant formula or pasteurized breast milk. The study will also evaluate the safety and tolerability of rhBSSL. Eligible patients will be randomized in a ratio of 1:1 (rhBSSL:placebo). The study consists of maximum 1 week screening period, a 4-week treatment period and a 2 year follow-up period.

Conditions

• Prevention of Growth Restriction

Interventions

Type	Name	Description
DRUG	rhBSSL (recombinant human bile-salt-stimulated lipase)	rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.
DRUG	Placebo	Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-07-01
• Completion: 2014-08-01
• First posted: 2011-08-10
• Last updated: 2015-07-30

Locations

49 sites across 10 countries: Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Russia, Spain, Sweden