| - candidate number | 2576 |
| - NTR Number | NTR968 |
| - ISRCTN | ISRCTN03720485 |
| - Date ISRCTN created | 30-mei-2007 |
| - date ISRCTN requested | 22-mei-2007 |
| - Date Registered NTR | 10-mei-2007 |
| - Secondary IDs | |
| - Public Title | Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections. |
| - Scientific Title | Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections. |
| - ACRONYM | NOA (Nederlands Onderzoek Adenotomie) |
| - hypothesis | 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. |
| - Healt Condition(s) or Problem(s) studied | Children, Randomised study, Adenoidectomy, Upper respiratory tract infection, Common cold, Rhinosinusitis |
| - 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) |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 1-apr-2007 |
| - planned closingdate | 1-feb-2010 |
| - Target number of participants | 110 |
| - Interventions | Adenoidectomy within 6 weeks versus watchful waiting. |
| - 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 |
| - Timepoints | |
| - Trial web site | NA |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Dr. Anne G.M. Schilder |
| - CONTACT for SCIENTIFIC QUERIES | Dr. 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 |
| - Publications | none |
| - Brief 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. |
| - Main changes (audit trail) | |
| - RECORD | 10-mei-2007 - 26-jul-2011 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl