Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
This study has been completed.
Sponsor:
Swedish Orphan Biovitrum
Information provided by:
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT00658905
First received: April 14, 2008
Last updated: August 4, 2009
Last verified: August 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 June 18, 2013