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Clinical Trials/ACTRN12617001652369
ACTRN12617001652369
Completed
未知

A multi-centre randomised controlled trial to compare nasal balloon autoinflation versus no nasal balloon autoinflation for otitis media with effusion in Aboriginal and Torres Strait Islander children

Western Sydney University0 sites150 target enrollmentDecember 22, 2017
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ConditionsOtitis Media with EffusionHealth of Aboriginal ChildrenEar - Other ear disordersInfection - Other infectious diseases

Overview

Phase
未知
Intervention
Not specified
Conditions
Otitis Media with Effusion
Sponsor
Western Sydney University
Enrollment
150
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 22, 2017
End Date
December 5, 2022
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Aboriginal and Torres Strait Islander
  • •2\. Aged 3 \-16 years
  • •3\. Type B tympanogram in at least one ear

Exclusion Criteria

  • •Child has current acute upper respiratory infection;
  • •Current acute otitis media (defined as a Type B tympanogram plus either ear pain or a bulging ear drum on otoscopy);
  • •Current perforated tympanic membrane or current grommet (ventilation tube);
  • •Planned ENT surgery within next 1 month;
  • •Children with a latex allergy;
  • •A nosebleed in the last 3 weeks, or more than 1 nosebleed in the preceding 6 months;
  • •A condition which increases the risk of complications (e.g. immunosuppression, genetic or chromosomal abnormality, cleft palate or mid\-face abnormalities such as seen in Down Syndrome)
  • •Inability to use the autoinflation device.
  • •Previous participation in INFLATE

Outcomes

Primary Outcomes

Not specified

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