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.
ID
Bron
Verkorte titel
Aandoening
English: Adenoidectomy, Upper respiratory tract infection, Common cold, Rhinosinusitis, Child, Randomised controlled trial
Dutch: Adenotomie, Bovenste luchtweginfectie, Verkoudheid, Rhinosinusitis, Kind
Ondersteuning
The Netherlands
number: 80-007022-98-07901
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Upper respiratory tract infection with or without fever (38°C or higher)
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
Adenoidectomy within 6 weeks versus watchful waiting.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Children aged 1-6 years selected for adenoidectomy primarily because of recurrent upper respiratory tract infections (common colds and rhinosinusitis).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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)
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL943 |
| NTR-old | NTR968 |
| Ander register | : |
| ISRCTN | ISRCTN03720485 |