The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS (OPTI-SURF)

May 30, 2025 updated by: Chiesi UK

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2973

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2TG
        • Birmingham Women's Hospital
      • Birmingham, United Kingdom, B9 5SS
        • Birmigham Heartlands Hospital
      • Bolton, United Kingdom, BL4 0JR
        • Royal Bolton Hospital
      • Bradford, United Kingdom
        • Bradford Royal Infirmary
      • Burnley, United Kingdom, BB10
        • Burnley General Hospital
      • Cambridge, United Kingdom, CB2 0SW
        • The Rosie Hospital
      • Chertsey, United Kingdom, KT16 0PZ
        • St Peter's Hospital
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • Liverpool, United Kingdom, L8 7SS
        • Liverpool Women's Hospital
      • London, United Kingdom, SW10 9NH
        • Chelsea And Westminster Hospital
      • London, United Kingdom, SE1 7EH
        • Guy's and St Thomas' Hospital
      • London, United Kingdom, E9 6SR
        • Homerton Hospital
      • London, United Kingdom, NW1 2BU'
        • University College Hospital
      • Manchester, United Kingdom, M13 9WL
        • St Mary's Hospital
      • Manchester, United Kingdom, M13
        • Wythenshawe Hospital
      • Middlesbrough, United Kingdom, TS4 3BW
        • The James Cook Hospital
      • Middlesbrough, United Kingdom
        • University Hospital of North Tees
      • Newcastle, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Queens Medical Centre
      • Oldham, United Kingdom, OL1 2JH
        • Royal Oldham Hospital
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital
      • Sheffield, United Kingdom, S10 2SF
        • Jessop Wing
      • Southampton, United Kingdom, SO16 6YD
        • Princess Anne Hospital
    • Kent
      • Ashford, Kent, United Kingdom, TN24 0LZ
        • William Harvey Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Newborn infants born in neonatal units in the UK

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Need for mechanical ventilation
Time Frame: Day 3 to 4 of life
Survival without mechanical ventilation (excluding days 1 and 2 of life)
Day 3 to 4 of life

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: To study completion, an average of 2 years
To study completion, an average of 2 years
Number of doses of surfactant
Time Frame: To study completion, an average of 2 years
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
To study completion, an average of 2 years
Survival with no respiratory support
Time Frame: On postnatal day 28
On postnatal day 28
Survival with no respiratory support
Time Frame: 36 weeks gestation
36 weeks gestation
Survival with no oxygen requirement
Time Frame: To study completion, an average of 2 years
To study completion, an average of 2 years
Duration of mechanical ventilation (days)
Time Frame: To study completion, an average of 2 years
To study completion, an average of 2 years
Duration of respiratory support (days)
Time Frame: To study completion, an average of 2 years
To study completion, an average of 2 years
Two-year developmental outcomes
Time Frame: Two years
As measured by Bailey's Score
Two years
Two-year developmental outcomes
Time Frame: Two years
As measured by Composite Developmental Assessment
Two years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Effect of dose on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2)
Time Frame: Day 3 to 4 of life
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)
Time Frame: Day 3 to 4 of life
Day 3 to 4 of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chiesi UK

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Imperial College London
The Leeds Teaching Hospitals NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kevin Goss, MBBS, Leeds Teaching Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRAS 237111
  • 36652 (Other Identifier: CPMS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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