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

Primary Purpose

Replacement Therapy in Preterm Infants

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
rhBSSL
Placebo
Sponsored by
Swedish Orphan Biovitrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Replacement Therapy in Preterm Infants focused on measuring Preterm infants, Replacement therapy, Infant formula, BSSL, BSSL is present in fresh mother's milk but not in infant formula.

Eligibility Criteria

undefined - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M.Lancisi -G.Salesi
  • Azienda Ospedaliera "Ospedale Policlinico Consorziale",U.O Neonatologia e Terapia Intensiva Neonatale
  • 3) U.O. di Neonatologia e Terapia Intensiva Neonatale Università degli Studi di Milano, Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena-Fondazione IRCCS
  • 4) Policlinico Universitario-Azienda Ospedaliera di Padova, Dipartimento di Pediatria
  • Clinical Pediatrica-Neonatologia, Policlinico Gemelli, Universita Cattolica
  • U.O. Neonatologia, Patologia Neonatale e Terapia Intensiva

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

rhBSSL

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Coefficient of Fat Absorption in stool

Secondary Outcome Measures

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

Full Information

First Posted
April 14, 2008
Last Updated
October 31, 2014
Sponsor
Swedish Orphan Biovitrum
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1. Study Identification

Unique Protocol Identification Number
NCT00658905
Brief Title
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Orphan Biovitrum

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Replacement Therapy in Preterm Infants
Keywords
Preterm infants, Replacement therapy, Infant formula, BSSL, BSSL is present in fresh mother's milk but not in infant formula.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rhBSSL
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
rhBSSL
Other Intervention Name(s)
bucelipase alfa (INN)
Intervention Description
0.15 g/L rhBSSL added to infant formula; one week treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One week treatment
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change in length and body weight between the start and end of each treatment period
Time Frame
Baseline and after one week of treatment

10. Eligibility

Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preterm infants less than or equal to 32 weeks of gestational age appropriate for gestational age enterally fed with infant formula
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Timdahl, MD
Organizational Affiliation
Biovitrum AB
Official's Role
Study Director
Facility Information:
Facility Name
Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M.Lancisi -G.Salesi
City
Ancona
Country
Italy
Facility Name
Azienda Ospedaliera "Ospedale Policlinico Consorziale",U.O Neonatologia e Terapia Intensiva Neonatale
City
Bari
Country
Italy
Facility Name
3) U.O. di Neonatologia e Terapia Intensiva Neonatale Università degli Studi di Milano, Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena-Fondazione IRCCS
City
Milano
Country
Italy
Facility Name
4) Policlinico Universitario-Azienda Ospedaliera di Padova, Dipartimento di Pediatria
City
Padova
Country
Italy
Facility Name
Clinical Pediatrica-Neonatologia, Policlinico Gemelli, Universita Cattolica
City
Rome
Country
Italy
Facility Name
U.O. Neonatologia, Patologia Neonatale e Terapia Intensiva
City
Rome
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25222806
Citation
Casper C, Carnielli VP, Hascoet JM, Lapillonne A, Maggio L, Timdahl K, Olsson B, Vagero M, Hernell O. rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):61-9. doi: 10.1097/MPG.0000000000000365.
Results Reference
derived

Learn more about this trial

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

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