Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants

Phase 2

Completed

• Conditions: Replacement Therapy in Preterm Infants
• Interventions: Drug: Placebo; Drug: rhBSSL

• Registration Number: NCT00658905
• Lead Sponsor: Swedish Orphan Biovitrum

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 patients will "crossover" to the other treatment regimen and receive an additional 7 days treatment. The primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-14
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-16
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-31
• Last Update Posted: 2014-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Preterm infants
• less than or equal to 32 weeks of gestational age
• appropriate for gestational age
• enterally fed with infant formula

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
rhBSSL	rhBSSL	-

Primary Outcome Measures

Name	Time	Method
Coefficient of Fat Absorption in stool	Stool collected for a 72-hour period during the final 3 days of each treatment period

Secondary Outcome Measures

Name	Time	Method
Change in length and body weight between the start and end of each treatment period	Baseline and after one week of treatment

Trial Locations

Locations (6)

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

Azienda Ospedaliera "Ospedale Policlinico Consorziale",U.O Neonatologia e Terapia Intensiva Neonatale; 🇮🇹 Bari, Italy

3) U.O. di Neonatologia e Terapia Intensiva Neonatale Università degli Studi di Milano, Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena-Fondazione IRCCS; 🇮🇹 Milano, Italy

4) Policlinico Universitario-Azienda Ospedaliera di Padova, Dipartimento di Pediatria; 🇮🇹 Padova, Italy

Clinical Pediatrica-Neonatologia, Policlinico Gemelli, Universita Cattolica; 🇮🇹 Rome, Italy

U.O. Neonatologia, Patologia Neonatale e Terapia Intensiva; 🇮🇹 Rome, Italy