ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620001184965

Ethics application status

Approved

Date submitted

13/09/2020

Date registered

9/11/2020

Date last updated

1/02/2022

Date data sharing statement initially provided

9/11/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Surfactant Administration by Supraglottic Airway for Preterm Infants with Respiratory Distress Syndrome: The SURFSUP 1 Trial

Scientific title

A multi-centre, randomised, controlled, non-inferiority trial in preterm infants with respiratory distress syndrome, comparing surfactant administration by supraglottic airway with minimally invasive surfactant therapy, assessing need for mechanical ventilation or repeat surfactant therapy within 72 hours of randomisation.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1258-2109

Trial acronym

SURFSUP 1

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Respiratory distress syndrome of prematurity

Condition category

Condition code

Reproductive Health and Childbirth

Complications of newborn

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

In the intervention group, the first dose of surfactant treatment for respiratory distress syndrome in preterm infants will be delivered by supraglottic airway device. The dose of surfactant administered will 200mg/kg and the surfactant formulation selected according to the standard in each participating centre. The supraglottic airway device (i-gel, size 1) will be inserted by a clinician trained in airway management. Correct position will be confirmed by colorimetric carbon dioxide detection. Surfactant will be administered over 2-3 minutes, via a catheter inserted into the distal end of the supraglottic airway. with the total procedure expected to take approximately 5-10 minutes. Adherence to the allocated treatment method will be monitored by direct entry of procedure data into the study data capture form.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

In the control group, the first dose of surfactant treatment for respiratory distress syndrome in preterm infants will be delivered by laryngoscopy and airway catheter, by neonatal clinical staff trained in airway management. The dose of surfactant administered will 200mg/kg and the surfactant formulation selected according to the standard in each participating centre. A thin catheter will be inserted into the airway under direct vision, using a standard neonatal laryngoscope (typically described in the literature as 'minimally invasive surfactant therapy' or 'MIST'). The specific devices used will be as per standard practice in each participating centre.

Control group

Active

Outcomes

Primary outcome [1]

Composite outcome of rate of mechanical ventilation and/or repeat surfactant treatment. These outcomes will be assessed as documented in the medical records by the treating clinical team.

Timepoint [1]

Within 72 hours of randomisation

Secondary outcome [1]

Incidence of bradycardia <100 bpm. This outcome will be assessed by direct entry into the study data capture form after completion of the procedure, with verification by an investigator after review of a video recording of the procedure.

Timepoint [1]

During the surfactant administration procedure

Secondary outcome [2]

Desaturation to SpO2 <80% lasting 30 seconds or more. This outcome will be assessed by direct entry into the study data capture form after completion of the procedure, with verification by an investigator after review of a video recording of the procedure.

Timepoint [2]

During the surfactant administration procedure

Secondary outcome [3]

Death. This outcome will be assessed as documented in the medical records by the treating clinical team.

Timepoint [3]

Prior to hospital discharge.

Secondary outcome [4]

Need for cardiopulmonary resuscitation (chest compressions). This outcome will be assessed as documented in the medical records by the treating clinical team.

Timepoint [4]

Within one hour of surfactant treatment

Secondary outcome [5]

Pneumothorax requiring drainage (needle aspiration or chest drain). This outcome will be assessed as documented in the medical records by the treating clinical team.

Timepoint [5]

Within 24 hours of randomisation

Secondary outcome [6]

Duration of respiratory support, which includes endotracheal mechanical ventilation, nasal intermittent positive pressure ventilation, nasal continuous positive airway pressure, and nasal high flow. This outcome will be assessed as documented in the medical records by the treating clinical team.

Timepoint [6]

This outcome will be assessed once at first hospital discharge.

Secondary outcome [7]

Duration of hospital admission. This outcome will be assessed as documented in the medical records by the treating clinical team.

Timepoint [7]

First discharge from hospital

Eligibility

Key inclusion criteria

Infants are eligible for inclusion in the trial if they meet all of the following criteria:
- Born preterm at less than 37 weeks’ gestation
- Birth weight 1250 g or above
- Age less than 48 hours
- Diagnosis of RDS, confirmed with chest x-ray or lung ultrasound, except where treatment is required urgently and would be delayed by imaging
- Required FiO2 0.30 or above to maintain target SpO2, on non-invasive respiratory support (CPAP/NIPPV or nHF)

Minimum age

No limit

Maximum age

48 Hours

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Infants are excluded from eligibility if they meet any of the following criteria:
- Previous treatment with surfactant or mechanical ventilation via an endotracheal tube
- Urgent need for intubation and mechanical ventilation as determined by the treating clinician
- Urgent need for surfactant prior to eligibility and consent criteria being met
- Known pneumothorax
- Major congenital anomaly of lungs, heart, or airway
- Not receiving full active intensive care (i.e. palliative/comfort care)

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation.
Stratification by centre and birth weight (less than 1500 g, and 1500 g and above)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The trial will assess the rate of mechanical ventilation or repeat surfactant treatment within 72 hours of randomisation. Our audit data indicate that for infants meeting the eligibility criteria for this trial, 76% of infants treated with minimally invasive surfactant therapy (MIST) successfully avoid mechanical ventilation or repeat surfactant treatment within 72 hours. We will assess whether supraglottic airway surfactant administration is non-inferior to surfactant administration by MIST, with a non-inferiority margin of 9%. If there is truly no difference in efficacy between groups, then 474 infants per group will be required, with 90% power and a two-sided 95% confidence interval, to demonstrate non-inferiority with a margin of 9%. To allow for a small proportion of exclusions (5% or fewer) from per-protocol analysis, we will recruit 500 infants per group: a total of 1000 infants.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

30/11/2020

Actual

21/02/2021

Date of last participant enrolment

Anticipated

10/11/2025

Actual

Date of last data collection

Anticipated

2/03/2026

Actual

Sample size

Target

1000

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Children’s Hospital - Clayton

Recruitment hospital [2]

The Royal Women's Hospital - Parkville

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

3052 - Parkville

Recruitment outside Australia

Country [1]

United Kingdom

State/province [1]

Scotland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421
Canberra
ACT 2601

Country [1]

Australia

Funding source category [2]

University

Name [2]

Monash University

Address [2]

Dept. of Paediatrics
Monash Children's Hospital
246 Clayton Rd
Clayton
VIC 3168

Country [2]

Australia

Primary sponsor type

Hospital

Name

Monash Health

Address

246 Clayton Rd
Clayton
VIC 3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee A

Ethics committee address [1]

246 Clayton Rd
Clayton
VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/09/2020

Approval date [1]

21/12/2020

Ethics approval number [1]

RES-20-0000-700A

Summary

Brief summary

Respiratory distress syndrome (RDS) is a condition found commonly in babies born prematurely, which results in breathing difficulty soon after birth, due to immaturity of the lungs. Many babies will be managed successfully with breathing support alone, but some require additional treatment with surfactant. Surfactant is a liquid that is applied directly into the baby’s airway, which helps open the lungs to make breathing easier
Currently, the standard method to administer surfactant requires laryngoscopy. This is where a doctor looks directly into the baby’s airway using a laryngoscope (a metal device that holds the airway open) and then inserts a tube into the airway to deliver the surfactant treatment. This method is very effective, but is challenging to learn, and may take more than one attempt even for experienced doctors. Also, during laryngoscopy, some babies may briefly have a drop in their heart rate or oxygen levels.
‘Supraglottic airways’ are a different type of device, made from a soft plastic, shaped to fit into the mouth and form a seal over the airway opening. They can be inserted without using a metal laryngoscope, and are easier to use for doctors and more comfortable for babies. Previous research suggests that surfactant treatment can be given through a supraglottic airway, but we do not yet know if this method is as effective as using direct laryngoscopy in helping the baby’s breathing. 
This research study will compare the new method, supraglottic airway surfactant treatment, with the current standard method, laryngoscopy. We will measure how stable babies are during surfactant treatment, including their oxygen levels and heart rate. We will also record how many babies need a higher level of breathing support (ventilation by a breathing tube), to determine how effective the treatment is in helping babies with RDS. If supraglottic airway surfactant treatment can be used safely and effectively, and is more comfortable and easy to use, it could become the preferred method of surfactant treatment for babies with RDS.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Calum Roberts

Address

Monash Children's Hospital
246 Clayton Rd
Clayton
VIC 3168

Country

Australia

Phone

+61385723933

Fax

calum.roberts@monashhealth.org

Contact person for public queries

Name

Calum Roberts

Address

Monash Children's Hospital
246 Clayton Rd
Clayton
VIC 3168

Country

Australia

Phone

+61385723933

Fax

calum.roberts@monashhealth.org

Contact person for scientific queries

Name

Calum Roberts

Address

Monash Children's Hospital
246 Clayton Rd
Clayton
VIC 3168

Country

Australia

Phone

+61385723933

Fax

calum.roberts@monashhealth.org

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual patient data after de-identification and removal of any data the could be used to triangulate identifiable information.

When will data be available (start and end dates)?

Beginning 1 year and ending 5 years after publication of the main results publication

Available to whom?

Case-by-case at discretion of trial steering committee. A methodologically sound research proposal and evidence of human research ethics committee approval will be required.

Available for what types of analyses?

Case-by-case discussion.

How or where can data be obtained?

Contact principal investigator (calum.roberts@monashhealth.org)

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9143	Study protocol				Will be provided at publication of main results.
9144	Statistical analysis plan				Will be provided at publication of main results.

Results publications and other study-related documents

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No additional documents have been identified.

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