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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50641733

Enrollment

Registered

2008-04-16

Start date

2007-09-24

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent acute otitis media Ear, Nose and Throat Otitis media

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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Occurrence of 1 episode of acute otitis media during the 3-month study period 2. Occurrence of adverse events	—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026