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

Not Applicable

Recruiting

• Conditions: Dysphonia.; Laryngeal abnormalities.; Intubation injury.; Hyperfunctional voice use.; Very preterm birth.; Reproductive Health and Childbirth - Complications of newborn; Physical Medicine / Rehabilitation - Speech therapy

• Registration Number: ACTRN12613001015730
• Lead Sponsor: Women and Infant's Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

Birth at less than 32 weeks gestation and admitted to the NICU at a single tertiary centre at birth.

Exclusion Criteria

Known disability likely to preclude compliance with assessment tasks.
Residence >200km from the study centre.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Voice quality, as measured by the severity score on the Consensus Auditory Perceptual Evaluation of Voice scale.[On clinical voice assessment in Phase I, immediately after recruitment to the study.];The presence of voice disturbance, defined as a score of 3.46 or above on the Acoustic Voice Quality Index.[On clinical voice assessment in Phase I, immediately after recruitment to the study.];Presence and severity of laryngeal pathology, as measured using the Stroboscopy Evaluation Rating Form.[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 Measures

Name	Time	Method
Voice-related quality of life restriction, as measured by the Pediatric Voice Handicap Index.[On clinical voice assessment in Phase I, immediately after recruitment to the study.];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.[After clinical voice assessment, prior to recruitment to Phase II (if applicable).]