The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
- Conditions
- Respiratory Distress SyndromeBronchopulmonary Dysplasia
- Registration Number
- NCT03808402
- Lead Sponsor
- Chiesi UK
- Brief Summary
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.
- Detailed Description
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.
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2973
- <37 weeks gestational age Requiring surfactant for Respiratory Distress Syndrome Record of birth weight available Born after study initiation
- 37 weeks gestation age or above Parental opt-out
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Need for mechanical ventilation Day 3 to 4 of life Survival without mechanical ventilation (excluding days 1 and 2 of life)
- Secondary Outcome Measures
Name Time Method Total cumulative dose of surfactant (excluding the first dose) To study completion, an average of 2 years Survival with no oxygen requirement To study completion, an average of 2 years Duration of mechanical ventilation (days) To study completion, an average of 2 years Duration of respiratory support (days) To study completion, an average of 2 years Survival To study completion, an average of 2 years Number of doses of surfactant To study completion, an average of 2 years Survival with no respiratory support 36 weeks gestation Two-year developmental outcomes Two years As measured by Composite Developmental Assessment
Trial Locations
- Locations (29)
William Harvey Hospital
🇬🇧Ashford, Kent, United Kingdom
Birmigham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
The Rosie Hospital
🇬🇧Cambridge, United Kingdom
University Hospital Coventry
🇬🇧Coventry, United Kingdom
St Peter's Hospital
🇬🇧Chertsey, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Homerton Hospital
🇬🇧London, United Kingdom
University College Hospital
🇬🇧London, United Kingdom
The James Cook Hospital
🇬🇧Middlesbrough, United Kingdom
University Hospital of North Tees
🇬🇧Middlesbrough, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle, United Kingdom
Queens Medical Centre
🇬🇧Nottingham, United Kingdom
Royal Oldham Hospital
🇬🇧Oldham, United Kingdom
Jessop Wing
🇬🇧Sheffield, United Kingdom
Princess Anne Hospital
🇬🇧Southampton, United Kingdom
Birmingham Women's Hospital
🇬🇧Birmingham, United Kingdom
Royal Bolton Hospital
🇬🇧Bolton, United Kingdom
Burnley General Hospital
🇬🇧Burnley, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Liverpool Women's Hospital
🇬🇧Liverpool, 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
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom