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

This study has been completed.
Sponsor:
Information provided by:
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT00658905
First received: April 14, 2008
Last updated: August 4, 2009
Last verified: August 2009
  Purpose

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


Condition Intervention Phase
Replacement Therapy in Preterm Infants
Drug: BSSL
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Swedish Orphan Biovitrum:

Primary Outcome Measures:
  • Coefficient of Fat Absorption in stool [ Time Frame: Stool collected for a 72-hour period during the final 3 days of each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in length and body weight between the start and end of each treatment period [ Time Frame: Baseline and after one week of treatment ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: BSSL
0.15 g/L rhBSSL added to infant formula; one week treatment
Other Name: bucelipase alfa (INN)
Placebo Comparator: 2 Drug: Placebo
One week treatment

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.

  Eligibility

Ages Eligible for Study:   up to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm infants
  • less than or equal to 32 weeks of gestational age
  • appropriate for gestational age
  • enterally fed with infant formula
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658905

Locations
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
U.O. Neonatologia, Patologia Neonatale e Terapia Intensiva
Rome, Italy
Clinical Pediatrica-Neonatologia, Policlinico Gemelli, Universita Cattolica
Rome, Italy
Sponsors and Collaborators
Swedish Orphan Biovitrum
Investigators
Study Director: Kristina Timdahl, MD Biovitrum AB
  More Information

No publications provided

Responsible Party: Maria Öhman, Biovitrum
ClinicalTrials.gov Identifier: NCT00658905     History of Changes
Other Study ID Numbers: BVT.BSSL-020
Study First Received: April 14, 2008
Last Updated: August 4, 2009
Health Authority: Italy: Agenzia Italiana del Farmaco - Ufficio Sperimentazione Clinica

Keywords provided by Swedish Orphan Biovitrum:
Preterm infants
Replacement therapy
Infant formula
BSSL
BSSL is present in fresh mother's milk but not in infant formula.

ClinicalTrials.gov processed this record on July 31, 2014