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17 May 2008
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| [ Print-friendly version ] |
| The efficacy of nasal cavity lavage with a physiological saline solution in prevention of recurrent acute otitis media: a pilot randomised controlled study |
| ISRCTN | ISRCTN50641733 |
| ClinicalTrials.gov identifier | |
| Public title | The efficacy of nasal cavity lavage with a physiological saline solution in prevention of recurrent acute otitis media: a pilot randomised controlled study |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | We believe that regular nasal irrigation with a physiological saline solution decreases the occurrence of acute otitis media (AOM) and recurrent acute otitis media (rOMA). |
| Ethics approval | Ethics approval received from the Comité d'éthique de la recherche du CHU Saint-Justine on the 28th May 2007 (ref: 2510), last amended 8th January 2008. |
| Study design | Randomised controlled pilot project |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Recurrent acute otitis media |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 24/09/2007 |
| Anticipated end date | 01/06/2008 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet. |
| Target number of participants | 40 |
| Interventions |
Intervention group:
Nasal irrigation with a physiological saline solution. A 0.9% saline solution is used. 1. If the child is not capable of blowing his nose: 1 cc (full dropper) per nostril, repeated twice, performed four times a day (QID) or six times daily during a respiratory infection 2. If the child is capable of blowing his nose: 5 vaporisations per nostril, blow nose and repeat a second time, perform QID or six times daily during a respiratory infection Control group: Patients in the control arm do not perform nasal irrigations. Treatment lasts 3 months and there are two follow-up visits at 6 weeks intervals. |
| Primary outcome measure(s) | 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 measure(s) |
1. Occurrence of 1 episode of acute otitis media during the 3-month study period
2. Occurrence of adverse events |
| Sources of funding | Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada) |
| Trial website | |
| Publications | |
| Contact name | Dr Annie Lapointe |
| Address | 3175 Cote Sainte-Catherine |
| City/town | Montreal |
| Zip/Postcode | H3T 1C5 |
| Country | Canada |
| Tel | +1 514 345 4857 |
| Fax | +1 514 345 4791 |
| annie.lapointe.hsj@ssss.gouv.qc.ca | |
| Sponsor | Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada) |
| Address | 3175 Côte Sainte-Catherine |
| City/town | Montreal |
| Zip/Postcode | H3T 1C5 |
| Country | Canada |
| Tel | +1 514 345 4691 |
| Fax | +1 514 345 4698 |
| centre@recherche-ste-justine.qc.ca | |
| Sponsor website: | http://www.recherche-sainte-justine.qc.ca/en/ |
| Date applied | 20/01/2008 |
| Last edited | 16/04/2008 |
| Date ISRCTN assigned | 16/04/2008 |
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