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

Replacement Therapy in Preterm Infants Clinical Trial

Official title:

A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Infant Formula Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658905
• Other study ID #: BVT.BSSL-020
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2008
• Last updated: October 31, 2014
• Start date: April 2008
• Est. completion date: May 2009

Study information

• Verified date: October 2014
• Source: Swedish Orphan Biovitrum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 32 Weeks

Eligibility

Inclusion Criteria:

• Preterm infants

• less than or equal to 32 weeks of gestational age

• appropriate for gestational age

• enterally fed with infant formula

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Replacement Therapy in Preterm Infants

Intervention

Drug:
• rhBSSL
0.15 g/L rhBSSL added to infant formula; one week treatment
• Placebo
One week treatment

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Orphan Biovitrum

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coefficient of Fat Absorption in stool		Stool collected for a 72-hour period during the final 3 days of each treatment period	No
Secondary	Change in length and body weight between the start and end of each treatment period		Baseline and after one week of treatment	No