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Trial registered on ANZCTR


Registration number
ACTRN12613001015730
Ethics application status
Approved
Date submitted
11/09/2013
Date registered
12/09/2013
Date last updated
12/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Voice disorders in very preterm children: incidence, presentation and influencing factors.
Scientific title
Voice disorders in very preterm children: an observational study of voice quality at school age, analysis of associated factors from retrospective chart review and investigation into laryngeal pathology of children with moderate to severe voice difficulties.
Secondary ID [1] 283189 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphonia. 290050 0
Laryngeal abnormalities. 290051 0
Intubation injury. 290054 0
Hyperfunctional voice use. 290055 0
Very preterm birth. 290056 0
Condition category
Condition code
Reproductive Health and Childbirth 290427 290427 0 0
Complications of newborn
Physical Medicine / Rehabilitation 290428 290428 0 0
Speech therapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Phase I Clinical Voice Assessment: the voice quality of 200 very preterm children with dysphonia will be clinically assessed at a single timepoint at school age. Clinical assessment will consist of an acoustic analysis of voice quality, perceptual ratings of voice quality, a quality-of-life questionnaire to be completed by a caregiver and a self-report questionnaire to be completed by the child. This assessment will take between 30 and 45 minutes, depending on the clinical presentation and discussion.

A number of medical variables will be determined via retrospective chart review. These include: birthweight, gestational age, frequency of intubation, duration of intubation and tube size to body weight ratio.

Phase II Fibreoptic Endoscopic Evaluation of Laryngeal Function: participants presenting with moderate to severe dysphonia will be offered a fibreoptic endoscopic evaluation of laryngeal function at a single time point. This evaluation will take approximately 30 minutes in total.
Intervention code [1] 287916 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290452 0
Voice quality, as measured by the severity score on the Consensus Auditory Perceptual Evaluation of Voice scale.
Timepoint [1] 290452 0
On clinical voice assessment in Phase I, immediately after recruitment to the study.
Primary outcome [2] 290453 0
The presence of voice disturbance, defined as a score of 3.46 or above on the Acoustic Voice Quality Index.
Timepoint [2] 290453 0
On clinical voice assessment in Phase I, immediately after recruitment to the study.
Primary outcome [3] 290454 0
Presence and severity of laryngeal pathology, as measured using the Stroboscopy Evaluation Rating Form.
Timepoint [3] 290454 0
After completion of clinical voice assessment in Phase I - Clinical Voice Assessment, on recruitment into Phase II - Fibreoptic Endoscopic Evaluation of Laryngeal Function.
Secondary outcome [1] 304544 0
Voice-related quality of life restriction, as measured by the Pediatric Voice Handicap Index.
Timepoint [1] 304544 0
On clinical voice assessment in Phase I, immediately after recruitment to the study.
Secondary outcome [2] 304562 0
Relationship between medical variables with the presence and severity of dysphonia: birthweight, gestational age, number of intubations, frequency of intubation, duration of intubation and tube size to body weight ratio.
Timepoint [2] 304562 0
After clinical voice assessment, prior to recruitment to Phase II (if applicable).

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
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
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
198
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287937 0
Charities/Societies/Foundations
Name [1] 287937 0
Telethon Trust, administered by the Women and Infant's Research Foundation
Country [1] 287937 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] 286658 0
None
Name [1] 286658 0
Address [1] 286658 0
Country [1] 286658 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289865 0
Princess Margaret Hospital Human Research Ethics Committee
Ethics committee address [1] 289865 0
Princess Margaret Hospital for Children
Roberts Road
SUBIACO WA 6008
Ethics committee country [1] 289865 0
Australia
Date submitted for ethics approval [1] 289865 0
Approval date [1] 289865 0
27/08/2012
Ethics approval number [1] 289865 0
1995EP
Ethics committee name [2] 289866 0
University of Western Australia Human Research Ethics Office
Ethics committee address [2] 289866 0
University of Western Australia
Hackett Drive
CRAWLEY WA 6009
Ethics committee country [2] 289866 0
Australia
Date submitted for ethics approval [2] 289866 0
Approval date [2] 289866 0
07/09/2012
Ethics approval number [2] 289866 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 phases I and II of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42830 0
A/Prof Noel French
Address 42830 0
King Edward Memorial Hospital
Bagot Rd
SUBIACO WA 6009
Country 42830 0
Australia
Phone 42830 0
+61 8 9340 1260
Fax 42830 0
Email 42830 0
[email protected]
Contact person for public queries
Name 42831 0
Victoria Reynolds
Address 42831 0
University of Western Australia
School of Paediatrics and Child Health
M561
Hackett Drive
Crawley WA 6009
Country 42831 0
Australia
Phone 42831 0
+61 438 749 005
Fax 42831 0
Email 42831 0
[email protected]
Contact person for scientific queries
Name 42832 0
Victoria Reynolds
Address 42832 0
University of Western Australia
School of Paediatrics and Child Health
M561
Hackett Drive
Crawley WA 6009
Country 42832 0
Australia
Phone 42832 0
+61 438 749 005
Fax 42832 0
Email 42832 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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