- Trials with a EudraCT protocol (2)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
2 result(s) found for: Pasteurized Milk.
Displaying page 1 of 1.
| EudraCT Number: 2007-002434-10 | Sponsor Protocol Number: BVT.BSSL-021 | Start Date*: 2007-10-17 |
| Sponsor Name:Biovitrum AB (publ.) | ||
| Full Title: A prospective, randomised, double-blind crossover study comparing 0.15 g/L rhBSSL added to pasteurized breast milk versus placebo during one week of treatment in preterm infants born before week 32... | ||
| Medical condition: Enzyme replacement therapy in pre-term infants. Reduced fat uptake capabilities due to prematurity of pre-term infants | ||
| Disease: | ||
| Population Age: Preterm newborn infants, Under 18 | Gender: Male, Female | |
| Trial protocol: FR (Completed) IT (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2010-023909-35 | Sponsor Protocol Number: BVT.BSSL-030 | Start Date*: 2011-06-24 | |||||||||||
| Sponsor Name:Swedish Orphan Biovitrum AB (publ) | |||||||||||||
| Full 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 Wee... | |||||||||||||
| Medical condition: Prevention of growth retardation due to lack of bile salt-stimulated lipase in enteral nutrition | |||||||||||||
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| Population Age: Preterm newborn infants, Under 18 | Gender: Male, Female | ||||||||||||
| Trial protocol: GB (Completed) BE (Prematurely Ended) SE (Prematurely Ended) DE (Prematurely Ended) HU (Completed) FR (Ongoing) CZ (Completed) PL (Prematurely Ended) ES (Prematurely Ended) IT (Completed) Outside EU/EEA | |||||||||||||
| Trial results: View results | |||||||||||||
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