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Trial registered on ANZCTR


Registration number
ACTRN12619000995178p
Ethics application status
Submitted, not yet approved
Date submitted
19/06/2019
Date registered
12/07/2019
Date last updated
12/07/2019
Date data sharing statement initially provided
12/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The SAINT Trial: Surfactant by supraglottic Airway versus direct laryngoscopy IN late preterm and Term newborns
Scientific title
Surfactant administration by either supraglottic airway device (SAD) or direct laryngoscopy in late preterm and term newborns on nasal continuous positive airway pressure (nCPAP): A randomised, multi-centre, non-inferiority trial
Secondary ID [1] 298540 0
None
Universal Trial Number (UTN)
U1111-1235-6800
Trial acronym
SAINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Distress Syndrome 313362 0
Condition category
Condition code
Respiratory 311805 311805 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 311806 311806 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supraglottic Airway Group
200mg/kg (2.5ml/kg) poractant alfa (Curosurf ®) surfactant administered via delivery tube following insertion of i-gel® supraglottic airway device.

The intervention will be delivered by either a Consultant Neonatologist, Neonatal Nurse Practitioner or a trainee Neonatal Registrar with the required clinical experience and expertise to undertake the task.

The i-gel is indicated for use in securing and maintaining a patent airway in routine and emergency anaesthetics. It provides a non-inflatable, anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures and has been recommended as an alternative to direct laryngoscopy and endotracheal intubation in newborn infants by the American Academy of Pediatrics. The i-gel will remain in position after surfactant administration until the newborn infants is clinically stable. This vary between infants from 1-5 minutes.
Intervention code [1] 314793 0
Treatment: Devices
Comparator / control treatment
Standard Care Group
200mg/kg (2.5ml/kg) poractant alfa (Curosurf ®) surfactant administered via delivery tube following direct laryngoscopy as per current practice at the individual study centres.
Control group
Active

Outcomes
Primary outcome [1] 320475 0
The primary outcome will be assessed on a hypothesis of non-inferiority. The primary outcome is:
• Respiratory severity score (mean airway pressure x FiO2)

Mean airway pressure will be the recorded from the medical records (either continuous pressure delivered via nasal continuous positive airway pressure (CPAP) or via high-flow nasal prongs. FiO2 will be recorded from the medical record and the fraction of inspired oxygen required to maintain the newborns oxygen saturation within normal limits. Normal saturation are defined as 90-94% for infants 34-36 weeks gestation and 94-98 for infants greater than 36 weeks gestation.
Timepoint [1] 320475 0
6 hours following surfactant administration
Secondary outcome [1] 371755 0
Duration and extent of desaturation from baseline calculated as area-under-the curve where x = duration (seconds) and y = desaturation from baseline (%SpO2) during procedure. %SpO2 will be measured by a massimo pulse oximeter and recorded for the duration of the intervention prior to downloading using custom software.
Timepoint [1] 371755 0
10 minutes post surfactant administration
Secondary outcome [2] 371756 0
Device (supraglottic airway, endotracheal tube, thin catheter) insertion attempts. This will be determined from the medical record.
Timepoint [2] 371756 0
Up to point of surfactant adminsitration
Secondary outcome [3] 371757 0
Number of doses of additional muscle relaxant or sedative during procedure (where used). This will be determined from the newborns medication chart.
Timepoint [3] 371757 0
up to point of surfactant adminstration
Secondary outcome [4] 371759 0
Administration of >/= 2 surfactant doses. This will be determined from the newborns medication chart.
Timepoint [4] 371759 0
Up to 6 hours post surfactant administration

Eligibility
Key inclusion criteria
Infants are eligible for inclusion in the study if:
• They are born at >33 weeks GA by best obstetric estimate and have a birth weight of >1500g; and
• They are <24 hours old at the time of randomisation; and
• They require nasal continuous positive airway pressure (nCPAP) after admission for moderate-to-severe respiratory distress, hypoxia or hypercapnia where the treating clinician has determined surfactant therapy is indicated and it is felt unlikely ongoing mechanical ventilation is required.
Minimum age
No limit
Maximum age
24 Hours
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants are excluded from the trial if:
• They have a known major congenital abnormality that may impact on the infants’ condition (including complex congenital cardiac disease, upper airway obstruction or complex airway abnormality, gastro-intestinal malformation; and
• They have previously been intubated (including intubation for suctioning below the cords in the delivery suite), or immediately need intubation, as a determined by the attending clinician.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Within each stratum, a 1:1 allocation ratio and block randomisation with variable block sizes (4 or 6) will be used. Multiple births with more than one eligible infant will be randomised individually.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Non-inferiority design
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The primary analysis will be by intention to treat. A secondary per-protocol analysis will also be performed for the primary outcome and any important differences reported, as per current recommendations for non-inferiority trials to safe-guard against the risk of falsely claiming non-inferiority.

Summary statistics will be presented as means (with standard deviations) for continuous variables and as frequencies (with percentages) for categorical variables. For all continuous variables (both primary and secondary outcomes) we will use the appropriate parametric (t-test) or non-parametric (Mann-Whitney U) test. The categorial variables will be analysed with Fisher’s exact test and Wilson’s estimate for the confidence interval of the absolute risk difference. The primary outcome will be assessed on a hypothesis of non-inferiority; all secondary outcomes will be assessed against a hypothesis of superiority.

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)
SA,VIC
Recruitment hospital [1] 14021 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 14022 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [3] 14023 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 26813 0
3168 - Clayton
Recruitment postcode(s) [2] 26811 0
5006 - North Adelaide
Recruitment postcode(s) [3] 26812 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 303086 0
Hospital
Name [1] 303086 0
Women's and Children's Hospital
Address [1] 303086 0
72 King William Road
North Adelaide
South Australia
5006
Country [1] 303086 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 King William Road
North Adelaide
South Australia
5006
Country
Australia
Secondary sponsor category [1] 303069 0
None
Name [1] 303069 0
Address [1] 303069 0
Country [1] 303069 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303631 0
Women's and Children's Health Network Human Ethics Committee
Ethics committee address [1] 303631 0
Research Secretariat
The Women's and Children's Hospital
72 King William Road
North Adelaide
SA
5006
Ethics committee country [1] 303631 0
Australia
Date submitted for ethics approval [1] 303631 0
11/07/2019
Approval date [1] 303631 0
Ethics approval number [1] 303631 0

Summary
Brief summary
A significant number of late preterm and term newborns require respiratory support and surfactant administration in the immediate newborn period for respiratory distress. Although there are many methods for delivery of surfactant, almost all require laryngoscopy. For those infants born outside a hospital with a neonatal intensive care nursery this requires emergency transport and mother-baby separation as the skill of laryngoscopy is mostly held in tertiary care centres. A supraglottic airway device (SAD) is recommended by the American Academy of Pediatrics as an alternative to direct laryngoscopy in later preterm and term newborns requiring resuscitation. It is particularly useful in non-tertiary settings where the skill of laryngoscopy is not available. It is the purpose of this study in late preterm and term newborns with respiratory distress, to determine if this approach is non-inferior in therapeutic effect, presents less risk to the infant and is more user friendly than standard approaches requiring laryngoscopy. If proven effective and safe, the ease of use of a SAD in this population would mean that it could be widely applied in non-tertiary special care nurseries, reducing the need for emergency transfer to a tertiary NICU – reducing costs and keeping mothers and babies together.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94330 0
A/Prof Michael Stark
Address 94330 0
Department of Neonatal Medicine
Level 1 Queen Victoria Building
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia
5006
Country 94330 0
Australia
Phone 94330 0
+61 8 83131325
Fax 94330 0
Email 94330 0
michael.stark@adelaide.edu.au
Contact person for public queries
Name 94331 0
A/Prof Michael Stark
Address 94331 0
Department of Neonatal Medicine
Level 1 Queen Victoria Building
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia
5006
Country 94331 0
Australia
Phone 94331 0
+61 83131325
Fax 94331 0
Email 94331 0
michael.stark@adelaide.edu.au
Contact person for scientific queries
Name 94332 0
A/Prof Michael Stark
Address 94332 0
Department of Neonatal Medicine
Level 1 Queen Victoria Building
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia
5006
Country 94332 0
Australia
Phone 94332 0
+61 8 83131325
Fax 94332 0
Email 94332 0
michael.stark@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator with a requirement to sign data access agreement.
Principle investigator contact: michael.stark@adelaide.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results