The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
NCT ID: NCT03808402
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2973 participants
OBSERVATIONAL
2018-10-26
2024-03-30
Brief Summary
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Detailed Description
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In 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.
Information regarding the dose of surfactant delivered, and the method of administration, are not currently routinely recorded in the UK.
The 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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High dose surfactant
Infants who receive a first dose of surfactant between 170 and 200 mg/kg
No interventions assigned to this group
Low dose surfactant
Infants who receive a first dose of surfactant between 100 and 130 mg/kg
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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The Leeds Teaching Hospitals NHS Trust
OTHER
Imperial College London
OTHER
Chiesi UK
INDUSTRY
Responsible Party
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Principal Investigators
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Kevin Goss, MBBS
Role: PRINCIPAL_INVESTIGATOR
Leeds Teaching Hospitals NHS Trust
Locations
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William Harvey Hospital
Ashford, Kent, United Kingdom
Birmingham Women's Hospital
Birmingham, , United Kingdom
Birmigham Heartlands Hospital
Birmingham, , United Kingdom
Royal Bolton Hospital
Bolton, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Burnley General Hospital
Burnley, , United Kingdom
The Rosie Hospital
Cambridge, , United Kingdom
St Peter's Hospital
Chertsey, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Liverpool Women's Hospital
Liverpool, , United Kingdom
Homerton Hospital
London, , United Kingdom
University College Hospital
London, , United Kingdom
Guy's and St Thomas' Hospital
London, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
St Mary's Hospital
Manchester, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
The James Cook Hospital
Middlesbrough, , United Kingdom
University Hospital of North Tees
Middlesbrough, , United Kingdom
Royal Victoria Infirmary
Newcastle, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Queens Medical Centre
Nottingham, , United Kingdom
Royal Oldham Hospital
Oldham, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Jessop Wing
Sheffield, , United Kingdom
Princess Anne Hospital
Southampton, , United Kingdom
Countries
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References
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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.
Related Links
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Other Identifiers
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36652
Identifier Type: OTHER
Identifier Source: secondary_id
IRAS 237111
Identifier Type: -
Identifier Source: org_study_id
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