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Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections.


- candidate number2576
- NTR NumberNTR968
- ISRCTNISRCTN03720485
- Date ISRCTN created30-mei-2007
- date ISRCTN requested22-mei-2007
- Date Registered NTR10-mei-2007
- Secondary IDs 
- Public TitleEffectiveness of adenoidectomy in children with recurrent upper respiratory tract infections.
- Scientific TitleEffectiveness of adenoidectomy in children with recurrent upper respiratory tract infections.
- ACRONYMNOA (Nederlands Onderzoek Adenotomie)
- hypothesisThis 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.
- Healt Condition(s) or Problem(s) studiedChildren, Randomised study, Adenoidectomy, Upper respiratory tract infection, Common cold, Rhinosinusitis
- Inclusion criteriaChildren aged 1-6 years selected for adenoidectomy primarily because of recurrent upper respiratory tract infections (common colds and rhinosinusitis).
- Exclusion criteria1. 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. Downs syndrome; 6. Craniofacial malformations (eg.cleft lip or palate)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-apr-2007
- planned closingdate1-feb-2010
- Target number of participants110
- InterventionsAdenoidectomy within 6 weeks versus watchful waiting.
- Primary outcomeUpper respiratory tract infection with or without fever (38C or higher)
- Secondary outcome1. 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
- Timepoints
- Trial web siteNA
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. Anne G.M. Schilder
- CONTACT for SCIENTIFIC QUERIESDr. Anne G.M. Schilder
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publicationsnone
- Brief summaryBackground: 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 (38C 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.
- Main changes (audit trail)
- RECORD10-mei-2007 - 26-jul-2011


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