NCT00659243 - Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

Conditions

Replacement Therapy in Preterm Infants

Interventions

DRUG

rhBSSL

0.15 g/L rhBSSL added to pasteurized breast milk; one week treatment

DRUG

Placebo

One week treatment

Trial Locations (8)

Hopital de la Croix Rousse, Lyon

Hopital la Conception,, Marseille

Maternité A. Pinard, Néonatologie, Nancy

Hopital Saint Vincent de Paul, Paris

Hopital des Enfants, Toulouse

CHRU de Tours, Centre de Pédiatrie Gatien de Clocheville, Tours

"Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G.Salesi", Ancona

Policlinico Universitario-Azienda Ospedeliero di Padova, Dipartimento di Pediatria, Padua