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Trial registered on ANZCTR


Registration number
ACTRN12620001205921
Ethics application status
Approved
Date submitted
29/06/2020
Date registered
12/11/2020
Date last updated
12/11/2020
Date data sharing statement initially provided
12/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the efficacy of sound stimuli for apnoea inhibition in preterm infants
Scientific title
Investigating the efficacy of sound stimuli for apnoea inhibition in preterm infants
Secondary ID [1] 301647 0
None
Universal Trial Number (UTN)
Trial acronym
ARIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Apnoea of prematurity 318061 0
Condition category
Condition code
Respiratory 316096 316096 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 317363 317363 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the intervention epochs, infants admitted to the neonatal intensive care unit and receiving non-invasive respiratory support will be monitored with beside cardiorespiratory and capsule pneumography monitor. When a respiratory pause lasting at least 3s is detected by the capsule pneumography monitor, the intervention (sound stimuli) will be delivered at a sound pressure of 55-65dB for a period of 10s using a wireless waterproof speaker placed in the infant’s humidicrib. If a respiratory pause last beyond the 10s stimuli, no additional stimuli will be delivered until respiratory effort is re-established. If a second respiratory pause occur when the 10s stimuli is being delivered, no second 10s stimuli will be delivered for the second respiratory pause.

Infants will be exposed to the Mother’s voice (arm 1) for 4h, and the non-vocal sound (arm 2) for 4h. As this is a crossover study design, consisting of two 4h intervention and two 4h control epochs in randomised sequence, with a 15 min washout period between epochs (i.e. infants will be exposed to both interventions, and each study will last a total of 16 hours).

Infants admitted to the neonatal intensive care unit are continuously monitored by nurses who responses to standard clinical alarms/concerns. Data will be recorded continuously including time when intervention is delivered, and any alarms, allowing us to monitor adherence to the intervention.
Intervention code [1] 317952 0
Treatment: Other
Comparator / control treatment
Two 4-h epochs of standard care, without any additional sound stimuli delivered. Infants will continue to be monitored via the capsule pneumography and cardiorespiratory monitors. As this is a crossover study, consisting of two 4h intervention and two 4h control epochs in randomised sequence, with a 15 min washout period between epochs.
Control group
Active

Outcomes
Primary outcome [1] 324291 0
Frequency of apnoea lasting >= 5 seconds, expressed as events per hour, detected by capsule pneumography.
Timepoint [1] 324291 0
Frequency of apnoea will be measured during each 4 h epoch of the crossover study (two intervention periods and two control periods).
Secondary outcome [1] 384249 0
Frequency of apnoea as per a consensus definition (Finer et al Pediatrics 2006;117:S47-S51), measured by a combination of capsule pneumography and cardiorespiratory monitoring.
Timepoint [1] 384249 0
Frequency of apnoea (consensus definition) will be measured during each 4 h epoch of the crossover study (two intervention periods and two control periods).
Secondary outcome [2] 384250 0
Frequency of apnoea-related hypoxic episodes (SpO2 <80% within 60 s of apnoea onset), measured by a combination of capsule pneumography and cardiorespiratory monitoring.
Timepoint [2] 384250 0
Frequency of apnoea-related hypoxia will be measured during each 4 h epoch of the crossover study (two intervention periods and two control periods).
Secondary outcome [3] 384251 0
Frequency of apnoea-related bradycardic episodes (HR <80 bpm within 60 s of apnoea onset), measured by a combination of capsule pneumography and cardiorespiratory monitoring.
Timepoint [3] 384251 0
Frequency of apnoea-related bradycardia will be measured during each 4 h epoch of the crossover study (two intervention periods and two control periods).

Eligibility
Key inclusion criteria
• Birth gestation of <30 weeks
• Chronological age of <4months
• Supported with non-invasive respiratory support, namely CPAP, or HFNC
• Agreement of treating clinician that the infant is suitable for inclusion in the study
Minimum age
0 Days
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Infant considered to be too unstable to be exposed to additional auditory stimuli.
• Escalation in respiratory support mode being contemplated in the next 24 hours.

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)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Crossover design, consisting of two 4h intervention and two 4h control epochs in randomised sequence, with a 15 min washout period between epochs.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Outcomes measures will be compared between each intervention epoch (Friedman ANOVA) and for each intervention against its respective control epoch (Wilcoxon matched pairs test). Recognizing the potential influence of period effects, a generalised linear mixed model with negative binomial error distribution will also be applied to examine the difference between interventions (mothers voice, non-vocal sound, none [i.e. standard care]), with an additional effect for epoch. A random effect term for participants will be included in the model to account for the non-independence of observations from the same participant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/11/2020
Actual
Date of last participant enrolment
Anticipated
15/11/2022
Actual
Date of last data collection
Anticipated
15/11/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 16990 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 30654 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 306081 0
Charities/Societies/Foundations
Name [1] 306081 0
Royal Hobart Hospital Research Foundation
Country [1] 306081 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Ave, Hobart TAS 7005
Country
Australia
Secondary sponsor category [1] 307526 0
Hospital
Name [1] 307526 0
Royal Hobart Hospital
Address [1] 307526 0
Liverpool St, Hobart, TAS
Country [1] 307526 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306302 0
Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [1] 306302 0
Ethics committee country [1] 306302 0
Australia
Date submitted for ethics approval [1] 306302 0
29/06/2020
Approval date [1] 306302 0
18/08/2020
Ethics approval number [1] 306302 0
23057

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

Contacts
Principal investigator
Name 103426 0
Prof Peter Dargaville
Address 103426 0
ROYAL HOBART HOSPITAL
GPO Box 1061L
HOBART TAS 7001
Country 103426 0
Australia
Phone 103426 0
+61 03 6166 8308
Fax 103426 0
Email 103426 0
Peter.dargaville@ths.tas.gov.au
Contact person for public queries
Name 103427 0
Peter Dargaville
Address 103427 0
ROYAL HOBART HOSPITAL
GPO Box 1061L
HOBART TAS 7001
Country 103427 0
Australia
Phone 103427 0
+61 03 6166 8308
Fax 103427 0
Email 103427 0
Peter.dargaville@ths.tas.gov.au
Contact person for scientific queries
Name 103428 0
Peter Dargaville
Address 103428 0
ROYAL HOBART HOSPITAL
GPO Box 1061L
HOBART TAS 7001
Country 103428 0
Australia
Phone 103428 0
+61 03 6166 8308
Fax 103428 0
Email 103428 0
Peter.dargaville@ths.tas.gov.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?

No Supporting Document Provided



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.