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Trial registered on ANZCTR


Registration number
ACTRN12613001012763
Ethics application status
Approved
Date submitted
29/08/2013
Date registered
11/09/2013
Date last updated
11/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Voice disorders in very preterm children: responsiveness to treatment.
Scientific title
A randomised, controlled trial of behavioural voice therapy in very preterm children with moderate to severe voice difficulties: effects on voice quality.
Secondary ID [1] 283109 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphonia. 289953 0
Intubation injury. 289954 0
Hyperfunctional voice use. 289955 0
Very preterm birth. 289956 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290326 290326 0 0
Speech therapy
Reproductive Health and Childbirth 290327 290327 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be offered 8 sessions of behavioural voice therapy, either immediately (experimental group) or following an 8 week delay (comparison group).

Behavioural voice therapy will target vocal hygiene information and counselling, indirect voice therapy targeting abdominal breathing and laryngeal relaxation, and direct voice therapy targeting easy onset phonation and resonant voice therapy.

Behavioural voice therapy will be administered one-on-one by a speech pathologist, in the presence of a caregiver to promote without session carryover of the therapy tasks.

Sessions will last for one hour and be administered once per week for eight weeks. In the event of cancellations and postponements, the therapy period will be extended to ensure that each participant receives the entire therapy over eight sessions.
Intervention code [1] 287828 0
Behaviour
Intervention code [2] 287829 0
Lifestyle
Intervention code [3] 287917 0
Treatment: Other
Comparator / control treatment
The comparison group will not be provided with treatment during the intervention window for the experimental group.
Control group
Active

Outcomes
Primary outcome [1] 290364 0
Dysphonia severity as measured by the Consensus Auditory Perceptual Evaluation of Voice rating scale.
Timepoint [1] 290364 0
For the experimental group, immediately after randomisation prior to commencement of intervention and after 8 weeks (at completion of treatment).

For the control group, on initial assessment (Phase I of study), 8 weeks after randomisation (period of no treatment) prior to commencement of intervention, and after a further 8 weeks (completion of treatment).
Primary outcome [2] 290365 0
Influence of voice on quality of life as measured by the Pediatric Voice Handicap Index rating scale.
Timepoint [2] 290365 0
For the experimental group, immediately after randomisation prior to commencement of intervention and after 8 weeks (at completion of treatment).

For the control group, on initial assessment (Phase I of study), 8 weeks after randomisation(period of no treatment) prior to commencement of intervention, and after a further 8 weeks (completion of treatment).
Primary outcome [3] 290366 0
Dysphonia severity as measured by the Acoustic Voice Quality Index.
Timepoint [3] 290366 0
For the experimental group, immediately after randomisation prior to commencement of intervention and after 8 weeks (at completion of treatment).

For the control group, on initial assessment (Phase I of study), 8 weeks after randomisation (period of no treatment) prior to commencement of intervention, and after a further 8 weeks (completion of treatment).
Secondary outcome [1] 304548 0
Voice quality, as measured by the GRBAS (Grade, Roughness, Breathiness, Aesthenia and Strain scale).
Timepoint [1] 304548 0
For the experimental group, immediately after randomisation prior to commencement of intervention and after 8 weeks (at completion of treatment).

For the control group, on initial assessment (Phase I of study), 8 weeks after randomisation (period of no treatment) prior to commencement of intervention, and after a further 8 weeks (completion of treatment).

Eligibility
Key inclusion criteria
Birth at less than 32 weeks gestation and admitted to the NICU at a single tertiary centre at birth.
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known disability likely to preclude compliance with assessment tasks.
Residence >200km from the study centre.

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)
Participants for this trial will be recruited from Phase I - Clinical voice assessment (quasirandomised recruitment) and Phase II - Fribeoptic Endoscopic Evaluation of Laryngeal Function (self-selection) and then randomised to either the experimental or control groups.
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
Other
Other design features
All participants will receive intervention. The experimental group will commence intervention immediately after randomisation, and the control group will receive therapy 8 weeks after randomisation to allow comparison of voice quality with and without intervention.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/10/2012
Actual
3/10/2012
Date of last participant enrolment
Anticipated
29/11/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287863 0
Charities/Societies/Foundations
Name [1] 287863 0
Telethon Trust, administered by the Women and Infant's Research Foundation
Country [1] 287863 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Women and Infant's Research Foundation
Address
C/O Carson House
Bagot Road
SUBIACO WA 6008
Country
Australia
Secondary sponsor category [1] 286592 0
None
Name [1] 286592 0
Address [1] 286592 0
Country [1] 286592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289806 0
Princess Margaret Hospital Human Research Ethics Committee
Ethics committee address [1] 289806 0
Princess Margaret Hospital for Children
Roberts Road
SUBIACO WA 6008
Ethics committee country [1] 289806 0
Australia
Date submitted for ethics approval [1] 289806 0
Approval date [1] 289806 0
27/08/2012
Ethics approval number [1] 289806 0
1995EP
Ethics committee name [2] 289807 0
University of Western Australia Human Research Ethics Office
Ethics committee address [2] 289807 0
University of Western Australia
Hackett Drive
CRAWLEY WA 6009
Ethics committee country [2] 289807 0
Australia
Date submitted for ethics approval [2] 289807 0
Approval date [2] 289807 0
07/09/2012
Ethics approval number [2] 289807 0
RA/4/1/5633

Summary
Brief summary
Greater numbers of children now survive preterm birth. Dysphonia is a newly-recognised long-term complication of extremely preterm birth, yet remains a relatively little-researched entity. Voice outcomes have been associated with gestational age, birthweight and cardiac surgery. However, the strongest association found has been with intubation in the neonatal period. Thus, there is a need to investigate voice quality of all who may be intubated.

Laryngeal pathology of very preterm children has not been systematically documented in the literature. Yet knowledge of laryngeal pathology is essential for intervention planning. Laryngeal pathology is investigated jointly by the Ear, Nose and Throat medical speciality and the Speech Pathology Voice allied health speciality.

Further, there has been no investigation of treatment effects in preterm voice disorders. Having identified that dysphonia is a long-term voice outcome for some preterm children, treatment options should be investigated.

Finally, many preterm children participate in paediatrician follow-up programmes to maximise medical and developmental outcomes. As dysphonia can now be considered a possible long-term complication for some preterm children, a screening tool for voice difficulties could be incorporated into existing follow-up programmes. The ideal measure would have: i) diagnostic accuracy to correctly identify the presence of dysphonia; ii) sensitivity to change in voice quality due to therapy; and iii) be quick and simple to administer to minimise cost.

This study consists of three phases: an observational study of voice quality and its impact on quality of life in 200 children born at less than 32 weeks gestation; assessment of the nature and extent of laryngeal pathology visualised in those children with moderate to severe dysphonia; and a quasi-randomised, non-blinded, controlled trial of behavioural voice therapy in the children with moderate to severe dysphonia. Additionally, the sensitivity to therapeutic change of an objective voice assessment, the Acoustic Voice Quality Index, validated by our laboratory as a measure of dysphonia severity in children, is being measured.

This registration pertains to Phase III Intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42534 0
A/Prof Noel French
Address 42534 0
King Edward Memorial Hospital
Bagot Rd
SUBIACO WA 6009
Country 42534 0
Australia
Phone 42534 0
+61 8 9340 1260
Fax 42534 0
Email 42534 0
[email protected]
Contact person for public queries
Name 42535 0
Victoria Reynolds
Address 42535 0
University of Western Australia
School of Paediatrics and Child Health
M561
Hackett Drive
Crawley WA 6009
Country 42535 0
Australia
Phone 42535 0
+61 438 749 005
Fax 42535 0
Email 42535 0
[email protected]
Contact person for scientific queries
Name 42536 0
Victoria Reynolds
Address 42536 0
University of Western Australia
School of Paediatrics and Child Health
M561
Hackett Drive
Crawley WA 6009
Country 42536 0
Australia
Phone 42536 0
+61 438 749 005
Fax 42536 0
Email 42536 0
[email protected]

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

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