Prevention of Growth Restriction Clinical Trial
Official title:
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
The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment