RecruitingACTRN12613001012763

Voice disorders in very preterm children: responsiveness to treatment.

A randomised, controlled trial of behavioural voice therapy in very preterm children with moderate to severe voice difficulties: effects on voice quality.


Sponsor

Women and Infant's Research Foundation

Enrollment

30 participants

Start Date

Oct 3, 2012

Study Type

Interventional

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 Phase III Intervention.


Eligibility

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

Plain Language Summary

Simplified for easier understanding

This study offers voice therapy to children who were born very early (before 32 weeks of pregnancy) and have developed voice problems (dysphonia). Being on a breathing tube in the neonatal intensive care unit (NICU) as a newborn can damage the vocal cords and affect how a child's voice sounds for years. This part of the study provides a therapy program to children aged 5–18 with moderate to severe voice problems and measures whether therapy improves the quality of their voice. 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 taking part in the 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

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

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.


Locations(1)

WA, Australia

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ACTRN12613001012763


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