Status:
TERMINATED
Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants
Lead Sponsor:
Swedish Orphan Biovitrum
Conditions:
Prevention of Growth Restriction
Eligibility:
All Genders
Up to 10 years
Phase:
PHASE3
Brief 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, rhBS...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
415 Patients enrolled
Trial Details
Trial ID
NCT01413581
Start Date
May 1 2011
End Date
August 1 2014
Last Update
July 30 2015
Active Locations (49)
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1
Swedish Orphan Biovitrum Investigational Site
Bruges, Belgium
2
Swedish Orphan Biovitrum Investigational Site
Leuven, Belgium
3
Swedish Orphan Biovitrum Investigational Site
Liège, Belgium
4
Swedish Orphan Biovitrum Investigational Site
Rocourt, Belgium