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Trial registered on ANZCTR


Registration number
ACTRN12613000589785
Ethics application status
Approved
Date submitted
21/05/2013
Date registered
24/05/2013
Date last updated
17/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can cervical auscultation improve the diagnosis of aspiration in children?
Scientific title
A randomised controlled trial comparing the effectiveness of clinical feeding evaluation versus clinical feeding evaluation with cervical auscultation in the diagnosis of aspiration in children.
Secondary ID [1] 282539 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oropharyngeal aspiration 289208 0
Condition category
Condition code
Respiratory 289537 289537 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children will receive either a clinical feeding examination only (CFE only) or clinical feeding examination + cervical auscultation (CFE+CA)assessment.

The CFE involves a case history and mealtime observations of the child’s oral sensorimotor, feeding and swallowing skills. The examination only provides an estimation of the co-ordination and movement of food/fluids through the pharyngeal phase. This is determined through visual observation of laryngeal movement, palpation of laryngeal movement and listening to clinical features (e.g. cough, wet voice, choking, voice change).

In the CFE+CA group, clinicians will be able to listen to the participant's breath and swallow sounds during the examination. A microphone is attached to the participants neck to allow access to cervical sounds generated during the swallow and breath sounds pre- and post-swallow.

All children will have a modified barium swallow (MBS) procedure (dynamic x-ray of the child's swallow in the oral and pharyngeal phases) after their clinical feeding evaluation. Timing of the MBS post clinical feeding evaluation is dependent on clinical constraints at the time of assessment and will range between 24 hrs to 2 weeks. Results of the MBS will be used to compare against their clinical assessment results.

Paticipants will undergo one assessment modality (CFE or CFE+CA) and one MBS only. Both assessment modalities will go for approximately 60 mins and the MBS procedure will go for approximately 30mins, with under 3 minutes of actual screening time.

All procedures and assessments will be completed by a speech pathologist, specialising in paediatric dysphagia mangagement at the Royal Children's Hospital, Brisbane. For MBS procedures, a radiographer and radiologist will also be present for the study.

The total duration of participant involvement in the study would be: CFE or CFE+CA (60mins) and MBS (30mins) = 90mins. No follow-up is necessary.
Intervention code [1] 287206 0
Early detection / Screening
Comparator / control treatment
There is no control group. This is an open, randomized controlled study, comparing 2 groups (CFE+CA vs CFE only) to MBS. Results of modified barium swallow will act as the control/comparator. Outcome measure: identified aspiration or no aspiration.

Participants will receive one assessment (CFE or CFE+CA) and one modified barium swallow (MBS). MBS will occur 24hrs to 2 weeks post assessment, pending clinical constraints. All participants will be assessed by a speech pathologist, specialising in paediatric dysphagia at The Royal Children's Hospital.
Control group
Active

Outcomes
Primary outcome [1] 289633 0
Modified barium swallow results: aspiration, penetration or no aspiration.
Timepoint [1] 289633 0
Clinical feeding evaluation (initial timepoint) followed by modified barium swallow study (end timepoint) within 24hrs to 2 weeks of initial clinical feeding evaluation assessment
Secondary outcome [1] 302897 0
Compare acoustic features of aspirating and non-aspirating swallow sounds (decibels, duration, frequency).Continuous variables will be analysed using a T-test (assuming normal distribution).
Timepoint [1] 302897 0
Clinical feeding evaluation only (first and end timepoint for this outcome)

Eligibility
Key inclusion criteria
Children aged under 18 years and who are referred for a feeding assessment or modified barium swallow study at The Royal Children's Hospital, Brisbane.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children deemed medically unfit to complete a clinical feeding evaluation and modifed barium swallow study as determined by the treating medical team. Children can only participate for one series of evaluations.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment
The parents/guardians of eligible children will be initially approached by the clinical speech pathologist responsible for the child’s assessment. Parents/guardians interested in participating will then be referred to the principle investigator (TTF). The study will be explained using written information statements and face-to-face interview. Written informed consent will be obtained from the parents/guardians of children enrolled. Written informed assent will also be obtained from young people aged 12 years and over.

Randomisation
A computer generated simple randomisation list, stratified by age (<1 year or =1 year) was produced by an external statistician. Allocation concealment will be maintained by group allocation (i.e. CFE or CFE+CA) being concealed in sequentially numbered, opaque envelopes until after consent and baseline information has been obtained. The envelope is opened in front of the treating speech pathologist and caregiver prior to the commencement of their feeding examination.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
We stratified by age because swallowing function is influenced by age. The cut-off of 12 months was chosen based on 2 factors; (a) the swallow-respiration pattern changes at 1 week and between 6 to 12 months of age;and (b) no statistically significant changes in temporal (i.e. durational) measures of a child’s swallow occurs between 2 to 15 months.
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
Sample size
We plan a sample size of 216 children based on previous research, where the sensitivity of CFE for OPA was 76%. 108 children per group provides 80% power (two-sided a = 0.05) to detect a 15% difference between two groups. A smaller difference between groups was considered insufficient to influence clinical practice.

Statistical analyses
Baseline characteristics of the two groups will be presented as means/medians or proportions and their 95% Confidence Intervals and compared using t-tests for normally distributed data, Chi-square tests for proportions and the appropriate non-parametric methods for non-normally distributed data. For our primary aim, agreement between OPA determined clinical and MBS assessments will be calculated using percent agreement and a kappa coefficient. Taking MBS determination of presence or absence of OPA as the gold standard, sensitivity, specificity, negative predictor value (NPV), positive predictor value (PPV), pretest probability and likelihood ratios will also be calculated. Likelihood ratios will also be calculated.

For our secondary aim, categorical variables of pre-, during and post-swallowing sound parameters will be analysed using a Chi-square test. Multivariate regression analysis will be used to determine if ages, gender, texture, method of intake or clinician level of experience are independent predictors on the absence/presence of particular swallowing sound parameters. The a priori statistical level of significance is p=0.05.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Preliminary analyses revealed 15% sig difference between groups
Date of first participant enrolment
Anticipated
27/09/2012
Actual
1/10/2012
Date of last participant enrolment
Anticipated
27/09/2014
Actual
30/08/2014
Date of last data collection
Anticipated
Actual
30/08/2014
Sample size
Target
216
Accrual to date
Final
152
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1043 0
Royal Children's Hospital - Herston
Recruitment postcode(s) [1] 6906 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 287323 0
Government body
Name [1] 287323 0
National Health & Medical Research Council
Country [1] 287323 0
Australia
Funding source category [2] 287324 0
Charities/Societies/Foundations
Name [2] 287324 0
Children's Health Queensland Foundation, Queensland Children's Medical Research Institute
Country [2] 287324 0
Australia
Funding source category [3] 287325 0
Charities/Societies/Foundations
Name [3] 287325 0
Speech Pathology Australia
Country [3] 287325 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Children's Health Queensland Foundation, Queensland Children's Medical Research Institute
Address
Level 4 Foundation Building
Royal Children's Hospital
Herston Rd
Herston , QLD, 4029
Country
Australia
Secondary sponsor category [1] 286070 0
None
Name [1] 286070 0
Address [1] 286070 0
Country [1] 286070 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289300 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 289300 0
Ethics committee country [1] 289300 0
Australia
Date submitted for ethics approval [1] 289300 0
29/09/2011
Approval date [1] 289300 0
29/09/2011
Ethics approval number [1] 289300 0
2011001295
Ethics committee name [2] 289301 0
Children’s Health Services Human Research Ethics Committee
Ethics committee address [2] 289301 0
Ethics committee country [2] 289301 0
Australia
Date submitted for ethics approval [2] 289301 0
16/05/2011
Approval date [2] 289301 0
16/05/2011
Ethics approval number [2] 289301 0
HREC/11/QRCH/52

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

Contacts
Principal investigator
Name 40222 0
Mrs Thuy Frakking
Address 40222 0
Level 4 Foundation Building
Queensland Children's Medical Research Institute
Royal Children's Hospital,
Herston, QLD, 4029.
Country 40222 0
Australia
Phone 40222 0
+61 7 3365 5121
Fax 40222 0
Email 40222 0
t.frakking@uq.edu.au
Contact person for public queries
Name 40223 0
Thuy Frakking
Address 40223 0
Level 4 Foundation Building
Queensland Children's Medical Research Institute
Royal Children's Hospital,
Herston, QLD, 4029.
Country 40223 0
Australia
Phone 40223 0
+61 7 3365 5121
Fax 40223 0
Email 40223 0
t.frakking@uq.edu.au
Contact person for scientific queries
Name 40224 0
Thuy Frakking
Address 40224 0
Level 4 Foundation Building
Queensland Children's Medical Research Institute
Royal Children's Hospital,
Herston, QLD, 4029.
Country 40224 0
Australia
Phone 40224 0
+61 7 3365 5121
Fax 40224 0
Email 40224 0
t.frakking@uq.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseCervical auscultation in the diagnosis of oropharyngeal aspiration in children: A study protocol for a randomised controlled trial.2013https://dx.doi.org/10.1186/1745-6215-14-377
EmbaseAspirating and Nonaspirating Swallow Sounds in Children: A Pilot Study.2016https://dx.doi.org/10.1177/0003489416669953
N.B. These documents automatically identified may not have been verified by the study sponsor.