Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
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
1 other identifier
interventional
33
1 country
6
Brief Summary
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2008
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 14, 2008
CompletedFirst Posted
Study publicly available on registry
April 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedNovember 3, 2014
October 1, 2014
1.1 years
April 14, 2008
October 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Coefficient of Fat Absorption in stool
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
Baseline and after one week of treatment
Study Arms (2)
rhBSSL
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Preterm infants
- less than or equal to 32 weeks of gestational age
- appropriate for gestational age
- enterally fed with infant formula
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
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
Milan, Italy
4) Policlinico Universitario-Azienda Ospedaliera di Padova, Dipartimento di Pediatria
Padua, Italy
Clinical Pediatrica-Neonatologia, Policlinico Gemelli, Universita Cattolica
Rome, Italy
U.O. Neonatologia, Patologia Neonatale e Terapia Intensiva
Rome, Italy
Related Publications (1)
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.
PMID: 25222806DERIVED
Study Officials
- STUDY DIRECTOR
Kristina Timdahl, MD
Biovitrum AB
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2008
First Posted
April 16, 2008
Study Start
April 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
November 3, 2014
Record last verified: 2014-10