Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT01203358
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2010-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'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'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C047049', 'term': 'dipalmitoylphosphatidylcholine, hexadecanol, tyloxapol drug combination'}, {'id': 'C072197', 'term': 'beractant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 617}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1991-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '1992-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-20', 'studyFirstSubmitDate': '2010-09-15', 'studyFirstSubmitQcDate': '2010-09-15', 'lastUpdatePostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1992-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death or bronchopulmonary dysplasia', 'timeFrame': '28 days of life'}], 'secondaryOutcomes': [{'measure': 'Average fraction of inspired oxygen (FIO2)', 'timeFrame': '72 hours after treatment'}, {'measure': 'Mean airway pressure (MAP)', 'timeFrame': '72 hours after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NICHD Neonatal Research Network', 'Extremely Low Birth Weight (ELBW)', 'Prematurity', 'Respiratory distress syndrome', 'Surfactant'], 'conditions': ['Infant, Newborn', 'Infant, Low Birth Weight', 'Infant, Small for Gestational Age', 'Infant, Premature', 'Bronchopulmonary Dysplasia']}, 'referencesModule': {'references': [{'pmid': '8229487', 'type': 'RESULT', 'citation': 'Horbar JD, Wright LL, Soll RF, Wright EC, Fanaroff AA, Korones SB, Shankaran S, Oh W, Fletcher BD, Bauer CR, et al. A multicenter randomized trial comparing two surfactants for the treatment of neonatal respiratory distress syndrome. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1993 Nov;123(5):757-66. doi: 10.1016/s0022-3476(05)80856-x.'}], 'seeAlsoLinks': [{'url': 'http://neonatal.rti.org/', 'label': 'NICHD Neonatal Research Network'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.', 'detailedDescription': 'The NICHD Neonatal Research Network conducted a randomized trial at 11 centers comparing the efficacy of two surfactants -- Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories) -- for the treatment of neonatal respiratory distress syndrome. Newborn infants with birth weights of 501-1500g with respiratory distress syndrome who were receiving assisted ventilation with 30% oxygen or more within 6 hours of birth were enrolled between January 1991 and January 1992. Infants were randomly assigned to receive up to four intratracheal doses of either Exosurf Neonatal or Survanta.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborn infants weighing 501 to 1500 gm with respiratory distress syndrome were receiving assisted ventilation with 30% oxygen or more\n\nExclusion Criteria:\n\n* Less than 6 hours of age'}, 'identificationModule': {'nctId': 'NCT01203358', 'acronym': 'Surfactant 1', 'briefTitle': 'Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome', 'organization': {'class': 'NETWORK', 'fullName': 'NICHD Neonatal Research Network'}, 'officialTitle': 'Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'NICHD-NRN-0003'}, 'secondaryIdInfos': [{'id': 'U01HD019897', 'link': 'https://reporter.nih.gov/quickSearch/U01HD019897', 'type': 'NIH'}, {'id': 'U10HD021364', 'link': 'https://reporter.nih.gov/quickSearch/U10HD021364', 'type': 'NIH'}, {'id': 'U10HD021373', 'link': 'https://reporter.nih.gov/quickSearch/U10HD021373', 'type': 'NIH'}, {'id': 'U10HD021385', 'link': 'https://reporter.nih.gov/quickSearch/U10HD021385', 'type': 'NIH'}, {'id': 'U10HD021397', 'link': 'https://reporter.nih.gov/quickSearch/U10HD021397', 'type': 'NIH'}, {'id': 'U10HD021415', 'link': 'https://reporter.nih.gov/quickSearch/U10HD021415', 'type': 'NIH'}, {'id': 'U10HD027856', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027856', 'type': 'NIH'}, {'id': 'U10HD027853', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027853', 'type': 'NIH'}, {'id': 'U10HD027871', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027871', 'type': 'NIH'}, {'id': 'U10HD027851', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027851', 'type': 'NIH'}, {'id': 'U10HD027880', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027880', 'type': 'NIH'}, {'id': 'U10HD027881', 'link': 'https://reporter.nih.gov/quickSearch/U10HD027881', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surfactant 1', 'description': 'Exosurf Neonatal (Burroughs Wellcome Co.)', 'interventionNames': ['Drug: Exosurf']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surfactant 2', 'description': 'Survanta (Ross Laboratories)', 'interventionNames': ['Drug: Survanta']}], 'interventions': [{'name': 'Exosurf', 'type': 'DRUG', 'otherNames': ['Exosurf Neonatal (Burroughs Wellcome Co.)'], 'description': 'Infants received up to four intratracheal doses of the surfactant.', 'armGroupLabels': ['Surfactant 1']}, {'name': 'Survanta', 'type': 'DRUG', 'otherNames': ['Survanta (Ross Laboratories)'], 'description': 'Infants received up to four intratracheal doses of the surfactant.', 'armGroupLabels': ['Surfactant 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '06504', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20052', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "Case Western Reserve University, Rainbow Babies and Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '05405', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Jeffrey D. Horbar, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Vermont'}, {'name': 'Elizabeth C. Wright, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Washington University'}, {'name': 'Avroy A. Fanaroff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}, {'name': 'Sheldon B. Korones, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tennessee'}, {'name': 'Seetha Shankaran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}, {'name': 'Charles R. Bauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}, {'name': 'Jon E. Tyson, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}, {'name': 'James A. Lemons, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'Edward F. Donovan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}, {'name': 'Barbara J. Stoll, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'David K. Stevenson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'LuAnn Papile, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NICHD Neonatal Research Network', 'class': 'NETWORK'}, 'responsibleParty': {'oldNameTitle': 'Jeffrey D. Horbar/ Lead Principal Investigator', 'oldOrganization': 'University of Vermont'}}}}