RecruitingACTRN12613001015730

Voice disorders in very preterm children: incidence, presentation and influencing factors.

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.


Sponsor

Women and Infant's Research Foundation

Enrollment

198 participants

Start Date

Oct 3, 2012

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 5 YearssMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates voice problems in children who were born very early (before 32 weeks of pregnancy). Being born very early and needing a breathing tube in the neonatal unit can affect the voice box (larynx), leading to a hoarse or rough voice that can last for years. This part of the study involves observing 200 children to find out how common voice problems are, what causes them, and how severely they affect quality of life. Children with more serious voice problems may then have their voice box examined more closely. You may be eligible if: - Your child was born before 32 weeks of pregnancy - Your child was admitted to the NICU at the study centre at birth - Your child is between 5 and 18 years old - Your child is male or female You may NOT be eligible if: - Your child has a disability that would prevent them from participating in assessments - You live more than 200 km from the study centre Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

WA, Australia

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ACTRN12613001015730


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