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NCT03808402 Clinical Trial

The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS

Bronchopulmonary Dysplasia Clinical Trial

— OPTI-SURF  

Official title:
The Effect of Surfactant Dose on Outcomes in Preterm Infants With Respiratory Distress Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03808402
Other study ID # IRAS 237111
Secondary ID 36652
Status Active, not recruiting
Phase
First received
Last updated
Start date October 26, 2018
Est. completion date January 30, 2024

Study information
Verified date August 2023
Source Chiesi UK
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Active, not recruiting
Enrollment 2973
Est. completion date January 30, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - <37 weeks gestational age Requiring surfactant for Respiratory Distress Syndrome Record of birth weight available Born after study initiation Exclusion Criteria: - 37 weeks gestation age or above Parental opt-out

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom William Harvey Hospital Ashford Kent
United Kingdom Birmigham Heartlands Hospital Birmingham
United Kingdom Birmingham Women's 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 Chelsea and Westminster Hospital London
United Kingdom Guy's and St Thomas' Hospital London
United Kingdom Homerton Hospital London
United Kingdom University College 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

Sponsors (3)
Lead Sponsor Collaborator
Chiesi UK Imperial College London, The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Other Effect of dose on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2) Day 3 to 4 of life
Other Effect of method of administration on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2) Day 3 to 4 of life
Primary Need for mechanical ventilation Survival without mechanical ventilation (excluding days 1 and 2 of life) Day 3 to 4 of life
Secondary Survival To study completion, an average of 2 years
Secondary Number of doses of surfactant To study completion, an average of 2 years
Secondary Total cumulative dose of surfactant (excluding the first dose) To study completion, an average of 2 years
Secondary Survival with no respiratory support On postnatal day 28
Secondary Survival with no respiratory support 36 weeks gestation
Secondary Survival with no oxygen requirement To study completion, an average of 2 years
Secondary Duration of mechanical ventilation (days) To study completion, an average of 2 years
Secondary Duration of respiratory support (days) To study completion, an average of 2 years
Secondary Two-year developmental outcomes As measured by Bailey's Score Two years
Secondary Two-year developmental outcomes As measured by Composite Developmental Assessment Two years
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