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Randomised prospective study of treatment methods for middle ear effusions in pre-school children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57358603
Enrollment
Unknown
Registered
2004-01-23
Start date
1994-04-01
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

Otitis media Ear, Nose and Throat Nonsuppurative otitis media

Interventions

1. Early treatment with ventilation tubes (grommets) 2. Watchful waiting for a period of nine months with analysis by intention to treat

Sponsors

NHS R&D Regional Programme Register - Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children born between April 1, 1991, and Dec 31, 1992, 2. Confirmed bilateral otitis media with effusion (OME) 3. Bilateral hearing impairment of 25-70 dB of at least 3 months' duration

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
Early surgery significantly reduced behavioural difficulty by 17% and the difference was largely mediated by concurrent hearing loss.—

Secondary

MeasureTime frame
Not provided at time of registration—

Countries

United Kingdom

Outcome results

None listed

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