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

• Growth velocity in grams per kilogram per day during 4 weeks of treatment. [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
  

• Change from baseline in body weight (g) at 3 months [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
  
• Body weight at 12 and 24 months' corrected age [ Time Frame: 12 and 24 months´ corrected age ] [ Designated as safety issue: No ]
  
• Change from baseline in total body length (mm) at 4 weeks [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
  
• Change from baseline in total body length (mm) at 3 months [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
  
• Time to readiness for discharge. [ Time Frame: Baseline to time point when readiness for discharge ] [ Designated as safety issue: No ]
  
• Time to discharge. [ Time Frame: Baseline to time for discharge ] [ Designated as safety issue: No ]
  
• Change from baseline in head circumference (mm) at 4 weeks. [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
  
• Head circumference (mm) at 3 months. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  
• Head circumference at 12 and 24 months' corrected age. [ Time Frame: 12 and 24 months´ corrected age ] [ Designated as safety issue: No ]
  
• Number and percentage of patients with treatment emergent AE, SAE and AE leading to discontinuation by system organ class and preferred term (coded by MedDRA) [ Time Frame: Baseline to Month 3 ] [ Designated as safety issue: Yes ]
  
• Change from baseline in Systolic Blood Pressure, Diastolic Blood Pressure and Heart Rate at 4 weeks [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: Yes ]
  
• Systolic Blood Pressure, Diastolic Blood Pressure and Heart Rate at 4 weeks [ Time Frame: Day 29 ] [ Designated as safety issue: Yes ]
  
• Number and percentage of patients with a clinically significant abnormal laboratory assessment during treatment [ Time Frame: Baseline to Day 29 ] [ Designated as safety issue: Yes ]
  
• Bayley Scale of Infant and Toddler Development [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  
• Neurodevelopment Disability Composite [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  
• Child Behavior Checklist [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  

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.