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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50641733 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/01/2008
- Registration date
- 16/04/2008
- Last edited
- 16/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Annie Lapointe
Scientific
Scientific
3175 Cote Sainte-Catherine
Montreal
H3T 1C5
Canada
| Phone | +1 514 345 4857 |
|---|---|
| annie.lapointe.hsj@ssss.gouv.qc.ca |
Study information
| Study design | Randomised controlled pilot project |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | Recurrent acute otitis media |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Saline solution |
| Primary outcome measure | 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 | 1. Occurrence of 1 episode of acute otitis media during the 3-month study period 2. Occurrence of adverse events |
| Overall study start date | 24/09/2007 |
| Completion date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/09/2007 |
| Date of final enrolment | 01/06/2008 |
Locations
Countries of recruitment
- Canada
Study participating centre
3175 Cote Sainte-Catherine
Montreal
H3T 1C5
Canada
H3T 1C5
Canada
Sponsor information
Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada)
Hospital/treatment centre
Hospital/treatment centre
3175 Côte Sainte-Catherine
Montreal
H3T 1C5
Canada
| Phone | +1 514 345 4691 |
|---|---|
| centre@recherche-ste-justine.qc.ca | |
| Website | http://www.recherche-sainte-justine.qc.ca/en/ |
"ROR" |
https://ror.org/01gv74p78 |
Funders
Funder type
Hospital/treatment centre
Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
