No registrations found.
ID
Source
Brief title
Health condition
English: Adenoidectomy, Upper respiratory tract infection, Common cold, Rhinosinusitis, Child, Randomised controlled trial
Dutch: Adenotomie, Bovenste luchtweginfectie, Verkoudheid, Rhinosinusitis, Kind
Sponsors and support
The Netherlands
number: 80-007022-98-07901
Intervention
Outcome measures
Primary outcome
Upper respiratory tract infection with or without fever (38°C or higher)
Secondary outcome
1. Acute otitis media and otitis media with effusion episodes;
2. Exhaled nitric oxide;
3. Nasopharyngeal flora;
4. Health related quality of life;
5. Cost-effectiveness
Background summary
Background: Convincing evidence regarding the effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections is lacking.
Aim: to detremine the effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections.
Study design: multi-centre randomized controlled trial.
Study population: 110 children aged 1-6 years selected for adenoidectomy primarily because of recurrent upper respiratory tract infections (common colds and rhinosinusitis).
Intervention: adenoidectomy within 6 weeks versus a watchful waiting strategy.
Follow-up: 2 years including symptom diaries, daily temperature measurements and follow-up visits at 3, 6, 12, 18 and 24 months.
Primary outcome: upper respiratory tract infections with or without fever (38°C or higher).
Secondary outcome: episodes of acute otitis media and otitis media with effusion, nasopharyngeal flora, exhaled nitric oxide, health related quality of life, cost-effectiveness.
Study objective
This is a superiority trial testing the hypothesis that adenoidectomy is more effective than a watchful waiting strategy in children with recurrent upper respiratory tract infections.
Intervention
Adenoidectomy within 6 weeks versus watchful waiting.
Wilhelmina Children's Hospital <br>
Department of Otorhinolaryngology <br>
PO Box 85090
Anne G.M. Schilder
Utrecht 3508 AB
The Netherlands
+31 (0)30 2504004
A.Schilder@umcutrecht.nl
Wilhelmina Children's Hospital <br>
Department of Otorhinolaryngology <br>
PO Box 85090
Anne G.M. Schilder
Utrecht 3508 AB
The Netherlands
+31 (0)30 2504004
A.Schilder@umcutrecht.nl
Inclusion criteria
Children aged 1-6 years selected for adenoidectomy primarily because of recurrent upper respiratory tract infections (common colds and rhinosinusitis).
Exclusion criteria
1. Age younger than 1 year or older than 6 years;
2. Previous adenoidectomy or adenotonsillectomy;
3. Tympanostomy tubes present;
4. Selected for adenoidectomy combined with tympanostomy tubes;
5. Down’s syndrome;
6. Craniofacial malformations (eg.cleft lip or palate)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL943 |
| NTR-old | NTR968 |
| Other | : |
| ISRCTN | ISRCTN03720485 |