Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-12 @ 3:14 AM
Study NCT ID:
NCT02305160
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2014-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Randomized, Open Label Trial of a New Animal Extracted Surfactant to Treat RDS in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C072197', 'term': 'beractant'}, {'id': 'C068291', 'term': 'poractant alfa'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 327}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-26', 'studyFirstSubmitDate': '2014-02-26', 'studyFirstSubmitQcDate': '2014-11-26', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': '72 hours after treatment', 'description': 'Mortality rate 72 hours after treatment'}], 'secondaryOutcomes': [{'measure': 'The incidence of adverse effects as: pneumothorax, pneumomediastinum, pulmonary interstitial emphysema, pulmonary hemorrhage and bronchopulmonary dysplasia (BPD).', 'timeFrame': '28 days of life', 'description': 'Incidence of main complications of prematurity at 28 days of life.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Respiratory distress syndrome', 'Pulmonary surfactant', 'Mortality', 'Prematurity'], 'conditions': ['Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '16680333', 'type': 'BACKGROUND', 'citation': 'Precioso AR, Sakae PP, Mascaretti RS, Kubrusly FS, Gebara VC, Iourtov D, Rebello CM, Vaz FA, Raw I. Analysis of the immunogenicity and stability of a porcine pulmonary surfactant preparation administered in rabbits. Clinics (Sao Paulo). 2006 Apr;61(2):153-60. doi: 10.1590/s1807-59322006000200011. Epub 2006 Apr 25.'}, {'pmid': '19191106', 'type': 'BACKGROUND', 'citation': 'Lyra JC, Mascaretti RS, Precioso AR, Haddad LB, Mauad T, Vaz FA, Rebello CM. Polyethylene glycol addition does not improve exogenous surfactant function in an experimental model of meconium aspiration syndrome. Exp Lung Res. 2009 Feb;35(1):76-88. doi: 10.1080/01902140802415837.'}, {'pmid': '25628188', 'type': 'DERIVED', 'citation': 'Rebello CM, Precioso AR, Mascaretti RS; Grupo Colaborativo do Estudo Brasileiro Multicentrico de Surfactante. A multicenter, randomized, double-blind trial of a new porcine surfactant in premature infants with respiratory distress syndrome. Einstein (Sao Paulo). 2014 Oct-Dec;12(4):397-404. doi: 10.1590/S1679-45082014AO3095.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy and safety of the new pulmonary surfactant produced by Butantan Institute among premature infants with gestational age below 34 weeks with RDS, comparing to the pulmonary surfactants commercially available in Brazil.', 'detailedDescription': 'Exogenous surfactant replacement therapy has been one of the major advances in the treatment of premature infants with respiratory distress syndrome (RDS). It has decreased the mortality among premature infants with RDS, determining changes in the children mortality rates among the developed countries. High cost, however, has been a major handicap for its wide use in developing and underdeveloped countries. Based on that, Butantan Institute (Sao Paulo, Brazil) has developed a new porcine pulmonary surfactant preparation at lower production cost. Initial animal studies showed similar improvement in lung mechanics and histopathologic findings to those observed with commercially available preparations.\n\nComparison(s): The new surfactant developed and produced by Butantan Institute will be compared to the commercially available pulmonary surfactants in Brazil, regarding to the efficiency to maintain a good arterial oxygenation, low airway pressures after treatment, similar mortality rates, and similar rates of complications like bronchopulmonary dysplasia and pulmonary hemorrhage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age below 34 weeks\n* RDS diagnosis based on clinical and RDS radiographic patterns\n* Need of mechanical ventilation\n* Parental consent\n\nExclusion Criteria:\n\n* Age greater than 24 hours\n* Major congenital malformations\n* Unstable hemodynamic status\n* Occurence of seizure during the stay in the Neonatal Intensive Care Unit\n* Maternal and/or fetal infection (chorioamnionitis: maternal fever, foul vaginal discharge, fetal tachycardia, uterine tenderness, leukocytosis or leukopenia) or congenital infection'}, 'identificationModule': {'nctId': 'NCT02305160', 'briefTitle': 'A Multicenter, Randomized, Open Label Trial of a New Animal Extracted Surfactant to Treat RDS in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Phase 3 Multicenter, Randomized, Open Label Trial of a New Low Cost Animal Extracted Surfactant to Treat Respiratory Distress Syndrome in Preterm Infants', 'orgStudyIdInfo': {'id': '012005B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Butantan', 'description': 'The new pulmonary surfactant produced by Butantan Institute. Butantan Surfactant: 100 mg/kg, IT, maximum of 3 doses.', 'interventionNames': ['Drug: Butantan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.', 'interventionNames': ['Drug: Control']}], 'interventions': [{'name': 'Butantan', 'type': 'DRUG', 'otherNames': ['Butantan Surfactant'], 'description': 'Use of Butantan surfactant 100 mg/kg, IT, maximum of 3 doses', 'armGroupLabels': ['Butantan']}, {'name': 'Control', 'type': 'DRUG', 'otherNames': ['Survanta or Curosurf'], 'description': 'The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45065-540', 'city': 'Vitória da Conquista', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital Esau de Matos', 'geoPoint': {'lat': -14.86611, 'lon': -40.83944}}, {'zip': '70673-423', 'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital Regional de Taguatinga', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'zip': '74673-200', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Hospital Materno Infantil', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '65020-460', 'city': 'São Luís', 'state': 'Maranhão', 'country': 'Brazil', 'facility': 'Hospital Universitario - Unidade Materno Infantil', 'geoPoint': {'lat': -2.52972, 'lon': -44.30278}}, {'zip': '30110-130', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Maternidade Odete Valadares', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '30140-080', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Santa Casa de Misericórdia de BH', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '30180-112', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Minas Gerais', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '30260-020', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital Sofia feldman', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '30575-740', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital Municipal Odilon Behrens', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '30620-470', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital Julia Kubstchek', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '50070-550', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'IMIP', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '50731-000', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Hospital Barao de Lucena', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '52030-010', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'CISAM - Universidade de Pernambuco', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '20010-010', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Maternidade Oswaldo de Nazareth', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '20720-292', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Maternidade Carmela Dutra', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '21610-645', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Maternidade Alexandre Fleming', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '22040-000', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Geral de Bonsucesso', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '22250-020', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto Fernandes Figueira', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '94950-585', 'city': 'Cachoeirinha', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Cachoeirinha', 'geoPoint': {'lat': -29.95111, 'lon': -51.09389}}, {'zip': '91430-001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Femina', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Grupo Hospital Criança Conceicao', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Alvorada', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '49060-640', 'city': 'Aracaju', 'state': 'Sergipe', 'country': 'Brazil', 'facility': 'Hospital Santa Isabel', 'geoPoint': {'lat': -10.91111, 'lon': -37.07167}}, {'zip': '49085-310', 'city': 'Aracaju', 'state': 'Sergipe', 'country': 'Brazil', 'facility': 'Maternidade Hildete Falcao Batista', 'geoPoint': {'lat': -10.91111, 'lon': -37.07167}}, {'zip': '18601-020', 'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculdade de Medicina de Botucatu - UNESP', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'zip': '13083-881', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade de Campinas - UNICAMP', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '14049-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'HC da Fac. de Medicina de Ribeirão Preto - USP', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '01224-010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Matern. Escola de Vila Nova Cachoeirinha', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto da Criança - HCFMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05508900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Universitario - USP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Alexander R Precioso, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sao Paulo Medical School Department of Pediatrics'}, {'name': 'Celso M Rebello, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo Medical School - Department of Pediatrics'}, {'name': 'Renata S Mascaretti, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sao Paulo Medical School Department of Pediatrics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Brazil', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Celso Moura Rebello', 'investigatorAffiliation': 'University of Sao Paulo'}}}}