Status:
COMPLETED
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
Lead Sponsor:
Swedish Orphan Biovitrum
Conditions:
Replacement Therapy in Preterm Infants
Eligibility:
All Genders
Up to 32 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.
Detailed Description
In this double-blind crossover study, patients will be randomized to receive infant formula including BSSL or infant formula without BSSL for the first 7 days. After a wash-out period of 2 days the pa...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Preterm infants
- less than or equal to 32 weeks of gestational age
- appropriate for gestational age
- enterally fed with infant formula
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00658905
Start Date
April 1 2008
End Date
May 1 2009
Last Update
November 3 2014
Active Locations (6)
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1
Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M.Lancisi -G.Salesi
Ancona, Italy
2
Azienda Ospedaliera "Ospedale Policlinico Consorziale",U.O Neonatologia e Terapia Intensiva Neonatale
Bari, Italy
3
3) U.O. di Neonatologia e Terapia Intensiva Neonatale Università degli Studi di Milano, Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena-Fondazione IRCCS
Milan, Italy
4
4) Policlinico Universitario-Azienda Ospedaliera di Padova, Dipartimento di Pediatria
Padua, Italy