We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620001184965p
Ethics application status
Submitted, not yet approved
Date submitted
13/09/2020
Date registered
9/11/2020
Date last updated
9/11/2020
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] 302293 0
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 319038 0
Condition category
Condition code
Reproductive Health and Childbirth 316994 316994 0 0
Complications of newborn
Respiratory 317330 317330 0 0
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] 318577 0
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] 325101 0
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] 325101 0
Within 72 hours of randomisation
Secondary outcome [1] 386842 0
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] 386842 0
During the surfactant administration procedure
Secondary outcome [2] 386843 0
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] 386843 0
During the surfactant administration procedure
Secondary outcome [3] 386844 0
Death. This outcome will be assessed as documented in the medical records by the treating clinical team.
Timepoint [3] 386844 0
Prior to hospital discharge.
Secondary outcome [4] 386845 0
Need for cardiopulmonary resuscitation (chest compressions). This outcome will be assessed as documented in the medical records by the treating clinical team.
Timepoint [4] 386845 0
Within one hour of surfactant treatment
Secondary outcome [5] 386846 0
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] 386846 0
Within 24 hours of randomisation
Secondary outcome [6] 386847 0
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] 386847 0
This outcome will be assessed once at first hospital discharge.
Secondary outcome [7] 386848 0
Duration of hospital admission. This outcome will be assessed as documented in the medical records by the treating clinical team.
Timepoint [7] 386848 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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 10%. If there is truly no difference in efficacy between groups, then 384 infants per group will be required, with 90% power and a two-sided 95% confidence interval, to demonstrate non-inferiority with a margin of 10%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17518 0
Monash Children’s Hospital - Clayton
Recruitment hospital [2] 17519 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 31248 0
3168 - Clayton
Recruitment postcode(s) [2] 31249 0
3052 - Parkville
Recruitment outside Australia
Country [1] 22983 0
United Kingdom
State/province [1] 22983 0
Scotland

Funding & Sponsors
Funding source category [1] 306935 0
Government body
Name [1] 306935 0
National Health and Medical Research Council
Address [1] 306935 0
GPO Box 1421
Canberra
ACT 2601
Country [1] 306935 0
Australia
Funding source category [2] 306936 0
University
Name [2] 306936 0
Monash University
Address [2] 306936 0
Dept. of Paediatrics
Monash Children's Hospital
246 Clayton Rd
Clayton
VIC 3168
Country [2] 306936 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Rd
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 307496 0
None
Name [1] 307496 0
None
Address [1] 307496 0
Country [1] 307496 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306888 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 306888 0
246 Clayton Rd
Clayton
VIC 3168
Ethics committee country [1] 306888 0
Australia
Date submitted for ethics approval [1] 306888 0
16/09/2020
Approval date [1] 306888 0
Ethics approval number [1] 306888 0

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 105354 0
Dr Calum Roberts
Address 105354 0
Monash Children's Hospital
246 Clayton Rd
Clayton
VIC 3168
Country 105354 0
Australia
Phone 105354 0
+61385723933
Fax 105354 0
Email 105354 0
calum.roberts@monashhealth.org
Contact person for public queries
Name 105355 0
Dr Calum Roberts
Address 105355 0
Monash Children's Hospital
246 Clayton Rd
Clayton
VIC 3168
Country 105355 0
Australia
Phone 105355 0
+61385723933
Fax 105355 0
Email 105355 0
calum.roberts@monashhealth.org
Contact person for scientific queries
Name 105356 0
Dr Calum Roberts
Address 105356 0
Monash Children's Hospital
246 Clayton Rd
Clayton
VIC 3168
Country 105356 0
Australia
Phone 105356 0
+61385723933
Fax 105356 0
Email 105356 0
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?
Study protocol
Statistical analysis plan
How or where can supporting documents be obtained?
Type [1] 9143 0
Study protocol
Citation [1] 9143 0
Link [1] 9143 0
Email [1] 9143 0
Other [1] 9143 0
Will be provided at publication of main results.
Attachment [1] 9143 0
Type [2] 9144 0
Statistical analysis plan
Citation [2] 9144 0
Link [2] 9144 0
Email [2] 9144 0
Other [2] 9144 0
Will be provided at publication of main results.
Attachment [2] 9144 0
Summary results
No Results