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

August 1, 2023 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

Active, not recruiting

Conditions

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

Observational

Enrollment (Actual)

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

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
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

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

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

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

Chiesi UK

Collaborators

Imperial College London
The Leeds Teaching Hospitals NHS Trust

Investigators

  • 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)

October 26, 2018

Primary Completion (Estimated)

January 30, 2024

Study Completion (Estimated)

January 30, 2024

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 17, 2019

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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