Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-03 @ 10:23 AM
Study NCT ID:
NCT00658905
Status:
COMPLETED
Last Update Posted:
2014-11-03
First Post:
2008-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-31', 'studyFirstSubmitDate': '2008-04-14', 'studyFirstSubmitQcDate': '2008-04-15', 'lastUpdatePostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coefficient of Fat Absorption in stool', 'timeFrame': 'Stool collected for a 72-hour period during the final 3 days of each treatment period'}], 'secondaryOutcomes': [{'measure': 'Change in length and body weight between the start and end of each treatment period', 'timeFrame': 'Baseline and after one week of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Preterm infants', 'Replacement therapy', 'Infant formula', 'BSSL', "BSSL is present in fresh mother's milk but not in infant formula."], 'conditions': ['Replacement Therapy in Preterm Infants']}, 'referencesModule': {'references': [{'pmid': '25222806', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants\n* less than or equal to 32 weeks of gestational age\n* appropriate for gestational age\n* enterally fed with infant formula'}, 'identificationModule': {'nctId': 'NCT00658905', 'briefTitle': 'Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Swedish Orphan Biovitrum'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BVT.BSSL-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rhBSSL', 'interventionNames': ['Drug: rhBSSL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'rhBSSL', 'type': 'DRUG', 'otherNames': ['bucelipase alfa (INN)'], 'description': '0.15 g/L rhBSSL added to infant formula; one week treatment', 'armGroupLabels': ['rhBSSL']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One week treatment', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'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', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'Azienda Ospedaliera "Ospedale Policlinico Consorziale",U.O Neonatologia e Terapia Intensiva Neonatale', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Milan', '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', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Padua', 'country': 'Italy', 'facility': '4) Policlinico Universitario-Azienda Ospedaliera di Padova, Dipartimento di Pediatria', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Clinical Pediatrica-Neonatologia, Policlinico Gemelli, Universita Cattolica', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'U.O. Neonatologia, Patologia Neonatale e Terapia Intensiva', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Kristina Timdahl, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biovitrum AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swedish Orphan Biovitrum', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}