The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
OPTI-SURF
2 other identifiers
observational
2,973
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Longer than P75 for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 26, 2018
CompletedFirst Submitted
Initial submission to the registry
January 14, 2019
CompletedFirst Posted
Study publicly available on registry
January 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedMay 31, 2025
May 1, 2025
5.4 years
January 14, 2019
May 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Need for mechanical ventilation
Survival without mechanical ventilation (excluding days 1 and 2 of life)
Day 3 to 4 of life
Secondary Outcomes (10)
Survival
To study completion, an average of 2 years
Number of doses of surfactant
To study completion, an average of 2 years
Total cumulative dose of surfactant (excluding the first dose)
To study completion, an average of 2 years
Survival with no respiratory support
On postnatal day 28
Survival with no respiratory support
36 weeks gestation
- +5 more secondary outcomes
Other Outcomes (2)
Effect of dose on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2)
Day 3 to 4 of life
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
Study Arms (2)
High dose surfactant
Infants who receive a first dose of surfactant between 170 and 200 mg/kg
Low dose surfactant
Infants who receive a first dose of surfactant between 100 and 130 mg/kg
Eligibility Criteria
Newborn infants born in neonatal units in the UK
You may qualify if:
- \<37 weeks gestational age Requiring surfactant for Respiratory Distress Syndrome Record of birth weight available Born after study initiation
You may not qualify if:
- weeks gestation age or above Parental opt-out
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chiesi UKlead
- The Leeds Teaching Hospitals NHS Trustcollaborator
- Imperial College Londoncollaborator
Study Sites (29)
William Harvey Hospital
Ashford, Kent, TN24 0LZ, United Kingdom
Birmingham Women's Hospital
Birmingham, B15 2TG, United Kingdom
Birmigham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Royal Bolton Hospital
Bolton, BL4 0JR, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Burnley General Hospital
Burnley, BB10, United Kingdom
The Rosie Hospital
Cambridge, CB2 0SW, United Kingdom
St Peter's Hospital
Chertsey, KT16 0PZ, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Liverpool Women's Hospital
Liverpool, L8 7SS, United Kingdom
Homerton Hospital
London, E9 6SR, United Kingdom
University College Hospital
London, NW1 2BU', United Kingdom
Guy's and St Thomas' Hospital
London, SE1 7EH, United Kingdom
Chelsea and Westminster Hospital
London, SW10 9NH, United Kingdom
St Mary's Hospital
Manchester, M13 9WL, United Kingdom
Wythenshawe Hospital
Manchester, M13, United Kingdom
The James Cook Hospital
Middlesbrough, TS4 3BW, United Kingdom
University Hospital of North Tees
Middlesbrough, United Kingdom
Royal Victoria Infirmary
Newcastle, Ne1 4LP, United Kingdom
Norfolk and Norwich University Hospital
Norwich, NR4 7UY, United Kingdom
Queens Medical Centre
Nottingham, NG7 2UH, United Kingdom
Royal Oldham Hospital
Oldham, OL1 2JH, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Queen Alexandra Hospital
Portsmouth, PO6 3LY, United Kingdom
Jessop Wing
Sheffield, S10 2SF, United Kingdom
Princess Anne Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
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.
PMID: 33310795DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Goss, MBBS
Leeds Teaching Hospitals NHS Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2019
First Posted
January 17, 2019
Study Start
October 26, 2018
Primary Completion
March 30, 2024
Study Completion
March 30, 2024
Last Updated
May 31, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
No plan to share IPD