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

Completed

Conditions: Recurrent acute otitis media
Ear, Nose and Throat
Otitis media

Registration Number: ISRCTN50641733

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

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
7. Cholesteatoma
8. Acute complication of AOM (intra- or extra-cranial)
9. History of ear, nose and throat (ENT) surgery (adenoidectomy, tonsillectomy, myringotomy or other)
10. Intra-nasal or systemic corticosteroid use (pulmonary steroids not excluded)
11. Adenoid or tonsil hypertrophy with suspicion of obstructive apnoea
12. Multiple allergies to antibiotics
13. Insufficient comprehension of written or spoken French by parents

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of recurrent acute otitis media (rAOM) defined as the occurrence of two distinct episodes of acute otitis media during the 3-month study period.

Secondary Outcome Measures