Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk 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 Pasteurized Breast Milk 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: NCT00659243
• Other study ID #: BVT.BSSL-021
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2008
• Last updated: October 31, 2014
• Start date: March 2008
• Est. completion date: February 2010

Study information

• Verified date: October 2014
• Source: Swedish Orphan Biovitrum
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)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 pasteurized breast milk.

Description:

In this double-blind crossover study, patients will be randomized to receive pasteurized breast milk including BSSL or pasteurized breast milk 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: 32
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• 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 pasteurized breast milk

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 pasteurized breast milk; one week treatment
• Placebo
One week treatment

Locations

Country	Name	City	State
France	Hopital de la Croix Rousse	Lyon
France	Hopital la Conception,	Marseille
France	Maternité A. Pinard, Néonatologie	Nancy
France	Hopital Saint Vincent de Paul	Paris
France	Hopital des Enfants	Toulouse
France	CHRU de Tours, Centre de Pédiatrie Gatien de Clocheville	Tours
Italy	Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M. Lancisi-G.Salesi"	Ancona
Italy	Policlinico Universitario-Azienda Ospedeliero di Padova, Dipartimento di Pediatria	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Orphan Biovitrum

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coefficient of Fat Absorption measured 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		Baseline and after one week of treatment	No