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Trial registered on ANZCTR


Registration number
ACTRN12622000577718p
Ethics application status
Submitted, not yet approved
Date submitted
7/12/2021
Date registered
19/04/2022
Date last updated
24/03/2024
Date data sharing statement initially provided
19/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot trial of the "Slider" continuous positive airway pressure (CPAP) therapy prongs for use in neonates with respiratory distress syndrome
Scientific title
Pilot trial of the efficacy of "Slider" continuous positive airway pressure (CPAP) therapy prongs for use in neonates with respiratory distress syndrome
Secondary ID [1] 305983 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory distress syndrome 324606 0
Condition category
Condition code
Reproductive Health and Childbirth 322059 322059 0 0
Complications of newborn
Respiratory 322201 322201 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The device will deliver continuous positive pressure (CPAP) to neonates with respiratory distress syndrome in place of the standard Fisher and Paykel prongs/mask. It will be utilized within the Mercy Womens Neonatal ICU by medical and nursing staff in neonates deemed appropriate. The duration of CPAP will be for the duration of clinical signs of respiratory distress syndrome in the baby. The mode of delivery of CPAP is via the Drager ventilator. In terms of recruitment, we hope to recruit 30 neonates within 1 year. The allocation is non-randomized and the first 30 infants recruited will receive the intervention. The location is within the Neonatal intensive care unit at the Mercy Womens Hospital which is a level 6 neonatal intensive care unit. Neonatal observations will be assessed by the chief investigator to assure adherence to the study protocol and correct use of the device
Intervention code [1] 322380 0
Treatment: Devices
Comparator / control treatment
The Fisher Paykel CPAP interface consists of two nasal prongs on a silicone base. Each nasal prong enters a nostril and although not designed to touch the nasal columella (skin covered part of the nasal septum) they regularly do and causes damage to the columella and underlying nasal septum, often within hours of such contact occurring. It is currently utilized within the Mercy Womens' Neonatal ICU, and many other Australian centers who deliver neonatal care by medical and nursing staff in neonates deemed appropriate.
The mode of delivery is via the Drager ventilator or drager bubble CPAP. The comparator is the mainstay of treatment for respiratory support in the neonatal ICU. The location is within the Neonatal intensive care unit at the Mercy Womens Hospital which is a level 6 neonatal intensive care unit. Neonatal observations and standard unit practice ensure correct use
Control group
Active

Outcomes
Primary outcome [1] 329823 0
The primary objective of this study is to evaluate use of Slider prongs to deliver effective CPAP to preterm infants in infants requiring CPAP for respiratory distress. This is a composite primary outcome as the parameters of heart rate, saturation and presence of apnoeas will be assessed to determine if the CPAP delivery with the slider prongs is successful This is done with standard clinical monitoring equipment such as ECG leads and pulse oximetry.
Timepoint [1] 329823 0
The trial participants will be assessed for the duration of their CPAP therapy and assessed using standard neonatal observations such as heart rate, respiratory rate, saturations and the presence or absence of apnoeas hourly for the duration of CPAP therapy
Secondary outcome [1] 403969 0
To determine the impact of the slider prongs on the rates of nasal trauma with slider prongs determined by clinical examination
Timepoint [1] 403969 0
Assessed daily for the duration of CPAP therapy until no longer required
Secondary outcome [2] 404478 0
Associated treatment failure within 72 hours of starting Slider prong CPAP assessed as requirement for intubation documented in patient medical records.
Timepoint [2] 404478 0
Over the period of CPAP use with daily assessment until CPAP therapy is deemed clinically complete and the infant no longer requires CPAP therapy. Failure rate is deemed as requirement for intubation within 72 hours of commencing CPAP therapy with the slider prongs.
Secondary outcome [3] 404482 0
Blood gas values assessed from patient medical records
Timepoint [3] 404482 0
The outcome will be assessed daily for the duration of cpap therapy from the patient medical records
Secondary outcome [4] 404483 0
The length of hospital stay assessed from medical and hospital records
Timepoint [4] 404483 0
Assessed from patient medical records at the time of discharge
Secondary outcome [5] 407723 0
Assessment of infant growth rate assessed using medical records
Timepoint [5] 407723 0
Assessed daily from the time of intervention commencement to the time of discharge
Secondary outcome [6] 407724 0
Incidence and/or grade of intraventricular haemorrhage assessed from medical records at the time of discharge
Timepoint [6] 407724 0
Assessed from medical records at the time of discharge
Secondary outcome [7] 407725 0
Incidence of confirmed sepsis assessed from medical records
Timepoint [7] 407725 0
Assessed from medical records at the time of discharge
Secondary outcome [8] 407726 0
Incidence of confirmed necrotizing enterocolitis (NEC) assessed from medical records
Timepoint [8] 407726 0
Assessed from medical record at the time of discharge
Secondary outcome [9] 407727 0
Incidence and if present grade of retinopathy of prematurity assessed from medical records
Timepoint [9] 407727 0
Assessed from medical records at the time of discharge
Secondary outcome [10] 407728 0
Death if any
Timepoint [10] 407728 0
Assessed from medical records at the time of study completion

Eligibility
Key inclusion criteria
Neonates who are greater than 28 weeks gestational age who have been stable on conventional CPAP for 24 hours previously but still have respiratory distress syndrome requiring CPAP treatment.
Minimum age
24 Hours
Maximum age
2 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Instability on CPAP requiring additional respiratory support or ventilation
Anatomical abnormalities impacting airway structure ie Cleft palate or Pierre Robin

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
31/05/2026
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 36157 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 310325 0
Commercial sector/Industry
Name [1] 310325 0
Bidibots
Country [1] 310325 0
Australia
Primary sponsor type
Individual
Name
Melissa Weber
Address
Mercy Hospital for Women, 163 Studley Rd, Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 311449 0
None
Name [1] 311449 0
Address [1] 311449 0
Country [1] 311449 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309985 0
Austin Health Ethics commitee
Ethics committee address [1] 309985 0
Ethics committee country [1] 309985 0
Australia
Date submitted for ethics approval [1] 309985 0
13/12/2021
Approval date [1] 309985 0
Ethics approval number [1] 309985 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116082 0
Dr Melissa Weber
Address 116082 0
Mercy Womens Hospital
Neonatal intensive care unit
Level 2
163 Studley Road
Heidelberg
VIC 3084
Country 116082 0
Australia
Phone 116082 0
+61 458468079
Fax 116082 0
Email 116082 0
mweber@mercy.com.au
Contact person for public queries
Name 116083 0
Melissa Weber
Address 116083 0
Mercy Womens Hospital
Neonatal intensive care unit
Level 2
163 Studley Road
Heidelberg
VIC 3084
Country 116083 0
Australia
Phone 116083 0
+61 458468079
Fax 116083 0
Email 116083 0
mweber@mercy.com.au
Contact person for scientific queries
Name 116084 0
Melissa Weber
Address 116084 0
Mercy Womens Hospital
Neonatal intensive care unit
Level 2
163 Studley Road
Heidelberg
VIC 3084
Country 116084 0
Australia
Phone 116084 0
+61 0384584444
Fax 116084 0
Email 116084 0
mweber@mercy.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14351Study protocol    383256-(Uploaded-27-03-2022-21-56-13)-Study-related document.doc



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.