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Clinical Trials/ISRCTN50641733
ISRCTN50641733
Completed
Not Applicable

The efficacy of nasal cavity lavage with a physiological saline solution in prevention of recurrent acute otitis media: a pilot randomised controlled study

Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada)0 sites40 target enrollmentApril 16, 2008
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ConditionsRecurrent acute otitis mediaEar, Nose and ThroatOtitis media

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Recurrent acute otitis media
Sponsor
Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada)
Enrollment
40
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 16, 2008
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada)

Eligibility Criteria

Inclusion Criteria

  • •1\. Age is between 6 months and 5 years old (exclusively), either sex
  • •2\. Recurrent acute otitis media (AOM) (diagnosed by paediatrician or referring general practitioner):
  • •2\.1\. Four AOM within 6 months
  • •2\.2\. Six AOM or more within 1 year

Exclusion Criteria

  • •1\. Parents refuse to participate
  • •2\. Known disease or syndrome modifying the normal anatomy or physiology or the upper respiratory tract (Downs, Apert, Crouzon, mucopolysaccharidosis, cranio\-cerebral trauma, etc.)
  • •3\. Malformations:
  • •3\.1\. Craniofacial, skull base or nose
  • •3\.2\. Complete or submucous cleft palate
  • •4\. Immunodeficiency:
  • •4\.1\. Congenital (according to paediatrician or immunologist)
  • •4\.2\. Acquired (human immunodeficiency virus \[HIV], chemotherapy)
  • •5\. Ciliary dysfunction (according to paediatrician or pneumologist)
  • •6\. Tympanic membrane perforation

Outcomes

Primary Outcomes

Not specified

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