Do children between 1 and 6 years suffering from recurrent acute otitis media benefit from treatment with grommets.

The effect of ventilation tubes on recurrent acute otitis media in children 1-6 years.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000380998

Acronym

NOROS

Enrollment

200

Registered

2011-04-13

Start date

2011-04-14

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

We want to find out if insertion of ventilation tubes reduces the number of ear infections, if the childs qaulity of life improves, and if the potential benefit of ventilation tube insertion outweighs the risks

Interventions

Insertion of ventilation tubes. Placing in the eardrum a grommet to ventilate the middle ear space. Administered under general anaesthetics. Duration 15 minutes.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

1 Years to 6 Years

Healthy volunteers

Inclusion criteria

4 episodes of acute otitis media during the last year or 3 episodes during the last 6 months; Childs caregivers must speak fluent english or norwegian

Exclusion criteria

Previous treatment with ventilation tubes; previous adenoidectomy or tonsillectomy; plans to move from district within follw-up time

Outcome results