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

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swedish Orphan Biovitrum
• Treatments: Bile Acids and Salts

Criteria

Inclusion Criteria:

• Preterm infants born before week 32 of gestation.

• Preterm infant who is less than 33 weeks postmenstrual age at the time of randomization.

• Preterm infant who is appropriate for gestational age (AGA) or small for gestational age (SGA) at birth.

• Preterm infant who is receiving food enterally (bottle or gavage tube) at a level of at least 100 ml/kg/day at randomization.

• Preterm infant whose enteral feeding consists of only infant formula or only pasteurized breast milk at the time of inclusion, and who are expected to remain on only infant formula for 4 weeks, or only pasteurized breast milk for at least 2 weeks following treatment initiation.

• Preterm infant who is expected not to receive any fresh breast milk for 4 weeks following treatment initiation.

• Informed consent is obtained.

Exclusion Criteria:

• Expected stay in the hospital is less than 4 weeks from the first dose of study drug.

• Criteria to ensure no disease or treatment affecting growth or development, e.g. brain disease, necrotizing enterocolitis.

• Enrolled in another concurrent clinical intervention study.