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

Swedish Orphan Biovitrum32 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Replacement Therapy in Preterm Infants

Interventions

rhBSSLDRUG

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

PlaceboDRUG

One week treatment

Eligibility

Sex: ALLMax age: 32 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * Preterm infants * less than or equal to 32 weeks of gestational age * appropriate for gestational age * enterally fed with pasteurized breast milk

Locations (8)

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

Outcomes

Primary Outcomes

Coefficient of Fat Absorption measured in stool

Time frame: Stool collected for a 72-hour period during the final 3 days of each treatment period

Secondary Outcomes

Change in length and body weight

Time frame: Baseline and after one week of treatment

Data from ClinicalTrials.gov

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