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

Sponsored by:	Biovitrum
Information provided by:	Biovitrum
ClinicalTrials.gov Identifier:	NCT00658905

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 II

MedlinePlus related topics: Infant and Toddler Nutrition

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by 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 ]

Estimated Enrollment:	32
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: BSSL 0.15 g/L rhBSSL added to infant formula; one week treatment
2: Placebo Comparator	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

Contacts

Contact: Thomas Bergefors, CSM	46-8-697-2000	thomas-cons.bergefors@biovitrum.com
Contact: Maria Öhman, MSc Pharm	46-8-697-2000	maria.ohman@biovitrum.com

Locations

Italy
Presidio Ospedaliero di Alta Specializzazione G.Salesi Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I-G.M.Lancisi -G.Salesi	Recruiting
Ancona, Italy
Clinical Pediatrica-Neonatologia, Policlinico Gemelli, Universita Cattolica	Recruiting
Rome, Italy
3) U.O. di Neonatologia e Terapia Intensiva Neonatale Università degli Studi di Milano, Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena-Fondazione IRCCS	Not yet recruiting
Milano, Italy
Azienda Ospedaliera "Ospedale Policlinico Consorziale",U.O Neonatologia e Terapia Intensiva Neonatale	Not yet recruiting
Bari, Italy
U.O. Neonatologia, Patologia Neonatale e Terapia Intensiva	Not yet recruiting
Rome, Italy
4) Policlinico Universitario-Azienda Ospedaliera di Padova, Dipartimento di Pediatria	Recruiting
Padova, Italy

Sponsors and Collaborators

Biovitrum

Investigators

Study Director:

Kristina Timdahl, MD

Biovitrum AB

More Information

No publications provided

Responsible Party:	Biovitrum ( Maria Öhman )
Study ID Numbers:	BVT.BSSL-020
Study First Received:	April 14, 2008
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00658905 History of Changes
Health Authority:	Italy: Agenzia Italiana del Farmaco - Ufficio Sperimentazione Clinica

Keywords provided by 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 May 07, 2009