Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT03808402
Status:
COMPLETED
Last Update Posted:
2025-05-31
First Post:
2019-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2973}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effect of dose on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2)', 'timeFrame': 'Day 3 to 4 of life'}, {'measure': 'Effect of method of administration on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2)', 'timeFrame': 'Day 3 to 4 of life'}], 'primaryOutcomes': [{'measure': 'Need for mechanical ventilation', 'timeFrame': 'Day 3 to 4 of life', 'description': 'Survival without mechanical ventilation (excluding days 1 and 2 of life)'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'To study completion, an average of 2 years'}, {'measure': 'Number of doses of surfactant', 'timeFrame': 'To study completion, an average of 2 years'}, {'measure': 'Total cumulative dose of surfactant (excluding the first dose)', 'timeFrame': 'To study completion, an average of 2 years'}, {'measure': 'Survival with no respiratory support', 'timeFrame': 'On postnatal day 28'}, {'measure': 'Survival with no respiratory support', 'timeFrame': '36 weeks gestation'}, {'measure': 'Survival with no oxygen requirement', 'timeFrame': 'To study completion, an average of 2 years'}, {'measure': 'Duration of mechanical ventilation (days)', 'timeFrame': 'To study completion, an average of 2 years'}, {'measure': 'Duration of respiratory support (days)', 'timeFrame': 'To study completion, an average of 2 years'}, {'measure': 'Two-year developmental outcomes', 'timeFrame': 'Two years', 'description': "As measured by Bailey's Score"}, {'measure': 'Two-year developmental outcomes', 'timeFrame': 'Two years', 'description': 'As measured by Composite Developmental Assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surfactant', 'Less Invasive Surfactant Administration', 'Mechanical Ventilation'], 'conditions': ['Respiratory Distress Syndrome', 'Bronchopulmonary Dysplasia']}, 'referencesModule': {'references': [{'pmid': '33310795', 'type': 'DERIVED', 'citation': 'Goss KCW, Gale C, Malone R, Longford N, Ratcliffe K, Modi N. Effect of surfactant dose on outcomes in preterm infants with respiratory distress syndrome: the OPTI-SURF study protocol. BMJ Open. 2020 Dec 12;10(12):e038959. doi: 10.1136/bmjopen-2020-038959.'}], 'seeAlsoLinks': [{'url': 'https://www.leedsth.nhs.uk/research/clinical-trials/optisurf/', 'label': 'Study website'}]}, 'descriptionModule': {'briefSummary': 'A prospective observational study using de-identified data from the Neonatal Network Research Database (NNRD) supplemented by additional information on dose, method of surfactant administration and dosing frequency to assess whether the dose and method of administration of surfactant given to preterm infants with respiratory distress syndrome (RDS) affects neonatal outcomes.', 'detailedDescription': "The rationale for this study is the clinical relevance of understanding whether surfactant dose affects neonatal outcomes in infants with RDS who are treated in the immediate postnatal period.\n\nIn a research environment, the dose of surfactant is rigorously controlled, usually administered at a dose of 100mg/kg or 200mg/kg. In clinical practice, clinicians more frequently follow the 'whole vial dosing' approach, where a full vial is given aiming to get as close as possible to the desired dose. Reasons for whole vial use include reduction of waste and administration of surfactant shortly after birth where an infant's weight is unknown. It is unclear whether whole vial dosing leads to under-dosing or over-dosing and whether either situation affects outcomes.\n\nInformation regarding the dose of surfactant delivered, and the method of administration, are not currently routinely recorded in the UK.\n\nThe primary objective of the study is to compare two dosing groups (100-130 mg/kg and 170-200 mg/kg) in terms of the proportions of infants who require mechanical ventilation within four days of birth."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newborn infants born in neonatal units in the UK', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<37 weeks gestational age Requiring surfactant for Respiratory Distress Syndrome Record of birth weight available Born after study initiation\n\nExclusion Criteria:\n\n* 37 weeks gestation age or above Parental opt-out'}, 'identificationModule': {'nctId': 'NCT03808402', 'acronym': 'OPTI-SURF', 'briefTitle': 'The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi UK'}, 'officialTitle': 'The Effect of Surfactant Dose on Outcomes in Preterm Infants With Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'IRAS 237111'}, 'secondaryIdInfos': [{'id': '36652', 'type': 'OTHER', 'domain': 'CPMS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'High dose surfactant', 'description': 'Infants who receive a first dose of surfactant between 170 and 200 mg/kg'}, {'label': 'Low dose surfactant', 'description': 'Infants who receive a first dose of surfactant between 100 and 130 mg/kg'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TN24 0LZ', 'city': 'Ashford', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'William Harvey Hospital', 'geoPoint': {'lat': 51.14648, 'lon': 0.87376}}, {'zip': 'B15 2TG', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': "Birmingham Women's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'B9 5SS', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Birmigham Heartlands Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BL4 0JR', 'city': 'Bolton', 'country': 'United Kingdom', 'facility': 'Royal Bolton Hospital', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'city': 'Bradford', 'country': 'United Kingdom', 'facility': 'Bradford Royal Infirmary', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'zip': 'BB10', 'city': 'Burnley', 'country': 'United Kingdom', 'facility': 'Burnley General Hospital', 'geoPoint': {'lat': 53.8, 'lon': -2.23333}}, {'zip': 'CB2 0SW', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'The Rosie Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'KT16 0PZ', 'city': 'Chertsey', 'country': 'United Kingdom', 'facility': "St Peter's Hospital", 'geoPoint': {'lat': 51.38812, 'lon': -0.50782}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'University Hospital Coventry', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Hull Royal Infirmary', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds General Infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'L8 7SS', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': "Liverpool Women's Hospital", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'E9 6SR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Homerton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': "NW1 2BU'", 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': "St Mary's Hospital", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'M13', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Wythenshawe Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'The James Cook Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'University Hospital of North Tees', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'Ne1 4LP', 'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Royal Victoria Infirmary', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'zip': 'NR4 7UY', 'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Queens Medical Centre', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'OL1 2JH', 'city': 'Oldham', 'country': 'United Kingdom', 'facility': 'Royal Oldham Hospital', 'geoPoint': {'lat': 53.54051, 'lon': -2.1183}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'PO6 3LY', 'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Queen Alexandra Hospital', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'zip': 'S10 2SF', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Jessop Wing', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Princess Anne Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Kevin Goss, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leeds Teaching Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi UK', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}, {'name': 'Imperial College London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}