Clinical trial NCT00658905: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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.
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2008-04-16
Enrollment: 33
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Coefficient of Fat Absorption in stool
timeFrame: Stool collected for a 72-hour period during the final 3 days of each treatment period
Secondary outcomes:
measure: Change in length and body weight between the start and end of each treatment period
timeFrame: Baseline and after one week of treatment
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M.Lancisi -G.Salesi
city: Bari
country: Italy
facility: Azienda Ospedaliera "Ospedale Policlinico Consorziale",U.O Neonatologia e Terapia Intensiva Neonatale
city: Milano
country: Italy
facility: 3) U.O. di Neonatologia e Terapia Intensiva Neonatale Università degli Studi di Milano, Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena-Fondazione IRCCS
city: Padova
country: Italy
facility: 4) Policlinico Universitario-Azienda Ospedaliera di Padova, Dipartimento di Pediatria
city: Rome
country: Italy
facility: Clinical Pediatrica-Neonatologia, Policlinico Gemelli, Universita Cattolica
city: Rome
country: Italy
facility: U.O. Neonatologia, Patologia Neonatale e Terapia Intensiva
Study officials:
affiliation: Biovitrum AB
name: Kristina Timdahl, MD
role: STUDY_DIRECTOR
References:
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.