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Completed

NCT Number: NCT00658905

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

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

Completed

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Key information

Conditions

Replacement Therapy in Preterm Infants

Age range

Up to 32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

rhBSSL

Drug

0.15 g/L rhBSSL added to infant formula; one week treatment

Other names: bucelipase alfa (INN)

Placebo

Drug

One week treatment

Primary outcomes

  1. Coefficient of Fat Absorption in stool

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

Secondary outcomes

  1. Change in length and body weight between the start and end of each treatment period

    Time frame: Baseline and after one week of treatment

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 16, 2008
Registry last updated
Nov 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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