Respiratory Distress SyndromeOPTI-SURFNCT03808402
The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
An observational study of Respiratory Distress Syndrome and Bronchopulmonary Dysplasia, run by Chiesi UK at 29 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
- How many people
- 2,973 participants
- Where
- 29 sitesUnited Kingdom
- Study dates
- 26 Oct 2018to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Newborn infants born in neonatal units in the UK
Who may be able to join
- <37 weeks gestational age Requiring surfactant for Respiratory Distress Syndrome Record of birth weight available Born after study initiation
Who cannot join
- 37 weeks gestation age or above Parental opt-out
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United Kingdom29 sites
William Harvey Hospital
Ashford, Kent, TN24 0LZ
Birmingham Women's Hospital
Birmingham, B15 2TG
Birmigham Heartlands Hospital
Birmingham, B9 5SS
Royal Bolton Hospital
Bolton, BL4 0JR
Bradford Royal Infirmary
Bradford
Burnley General Hospital
Burnley, BB10
The Rosie Hospital
Cambridge, CB2 0SW
St Peter's Hospital
Chertsey, KT16 0PZ
University Hospital Coventry
Coventry, CV2 2DX
Hull Royal Infirmary
Hull, HU3 2JZ
Leeds General Infirmary
Leeds, LS1 3EX
Leicester Royal Infirmary
Leicester, LE1 5WW
Liverpool Women's Hospital
Liverpool, L8 7SS
Homerton Hospital
London, E9 6SR
University College Hospital
London, NW1 2BU'
Guy's and St Thomas' Hospital
London, SE1 7EH
Chelsea and Westminster Hospital
London, SW10 9NH
St Mary's Hospital
Manchester, M13 9WL
Wythenshawe Hospital
Manchester, M13
The James Cook Hospital
Middlesbrough, TS4 3BW
University Hospital of North Tees
Middlesbrough
Royal Victoria Infirmary
Newcastle, Ne1 4LP
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
Queens Medical Centre
Nottingham, NG7 2UH
Royal Oldham Hospital
Oldham, OL1 2JH
John Radcliffe Hospital
Oxford, OX3 9DU
Queen Alexandra Hospital
Portsmouth, PO6 3LY
Jessop Wing
Sheffield, S10 2SF
Princess Anne Hospital
Southampton, SO16 6YD
About this study
Official title: The Effect of Surfactant Dose on Outcomes in Preterm Infants With Respiratory Distress Syndrome
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.
Read the 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.
- Keywords
- Surfactant, Less Invasive Surfactant Administration, Mechanical Ventilation
- Medical subject headings
- Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for mechanical ventilation
Survival without mechanical ventilation (excluding days 1 and 2 of life)
Measured: Day 3 to 4 of life
Secondary outcomes (10)
Survival
Measured: To study completion, an average of 2 years
Number of doses of surfactant
Measured: To study completion, an average of 2 years
Total cumulative dose of surfactant (excluding the first dose)
Measured: To study completion, an average of 2 years
Survival with no respiratory support
Measured: On postnatal day 28
Survival with no respiratory support
Measured: 36 weeks gestation
Survival with no oxygen requirement
Measured: To study completion, an average of 2 years
Duration of mechanical ventilation (days)
Measured: To study completion, an average of 2 years
Duration of respiratory support (days)
Measured: To study completion, an average of 2 years
Two-year developmental outcomes
As measured by Bailey's Score
Measured: Two years
Two-year developmental outcomes
As measured by Composite Developmental Assessment
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start26 Oct 2018
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Leeds Teaching Hospitals NHS Trust, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Kevin Goss, MBBS, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808402
- Sponsor's protocol ID
- IRAS 237111
- Other IDs
- 36652
- Acronym
- OPTI-SURF
- Status last verified
- May 2025
- First submitted
- 14 Jan 2019
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Publications
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.
PubMed 33310795
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Surfactant Dose on Outcomes in Preterm Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03808402
- Acronym / sponsor ID
- OPTI-SURF / IRAS 237111
- Keywords
- Surfactant, Less Invasive Surfactant Administration, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,973 participants (actual)
- Lead sponsor
- Chiesi UKIndustry (pharma, biotech, devices)
- Collaborators
- The Leeds Teaching Hospitals NHS Trust, Imperial College London
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newborn infants born in neonatal units in the UK
Key inclusion criteria (1 listed)
- <37 weeks gestational age Requiring surfactant for Respiratory Distress Syndrome Record of birth weight available Born after study initiation
Key exclusion criteria (1 listed)
- 37 weeks gestation age or above Parental opt-out
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Need for mechanical ventilation
Time frame: Day 3 to 4 of life
Survival without mechanical ventilation (excluding days 1 and 2 of life)
10 secondary outcomes
Survival
Time frame: To study completion, an average of 2 years
Number of doses of surfactant
Time frame: To study completion, an average of 2 years
Total cumulative dose of surfactant (excluding the first dose)
Time frame: To study completion, an average of 2 years
Survival with no respiratory support
Time frame: On postnatal day 28
Survival with no respiratory support
Time frame: 36 weeks gestation
Survival with no oxygen requirement
Time frame: To study completion, an average of 2 years
Duration of mechanical ventilation (days)
Time frame: To study completion, an average of 2 years
Duration of respiratory support (days)
Time frame: To study completion, an average of 2 years
Two-year developmental outcomes
Time frame: Two years
Two-year developmental outcomes
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Derived from this study: PubMed 33310795Goss 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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Goss, MBBS principal investigator
Leeds Teaching Hospitals NHS Trust
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome and Bronchopulmonary Dysplasia, run by Chiesi UK at 29 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for mechanical ventilation (time frame: Day 3 to 4 of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03808402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.