Condition category
Ear, Nose and Throat
Date applied
20/01/2008
Date assigned
16/04/2008
Last edited
16/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Annie Lapointe

ORCID ID

Contact details

3175 Cote Sainte-Catherine
Montreal
H3T 1C5
Canada
+1 514 345 4857
annie.lapointe.hsj@ssss.gouv.qc.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

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

Phase

Not Specified

Drug names

Saline solution

Primary outcome measures

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 trial start date

24/09/2007

Overall trial end date

01/06/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

24/09/2007

Recruitment end date

01/06/2008

Locations

Countries of recruitment

Canada

Trial participating centre

3175 Cote Sainte-Catherine
Montreal
H3T 1C5
Canada

Sponsor information

Organisation

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

Sponsor details

3175 Côte Sainte-Catherine
Montreal
H3T 1C5
Canada
+1 514 345 4691
centre@recherche-ste-justine.qc.ca

Sponsor type

Hospital/treatment centre

Website

http://www.recherche-sainte-justine.qc.ca/en/

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes