Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections
| ISRCTN | ISRCTN03720485 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03720485 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/05/2007
- Registration date
- 30/05/2007
- Last edited
- 21/01/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anne G.M. Schilder
Scientific
Scientific
University Medical Centre Utrecht (UMCU)
Wilhelmina Children's Hospital
Department of Otorhinolaryngology
P.O. Box 85090
Utrecht
3508 AB
Netherlands
| Phone | +31 (0)30 250 4004 |
|---|---|
| A.Schilder@umcutrecht.nl |
Study information
| Study design | Randomised, multicentre, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | NOA (Nederlands Onderzoek Adenotomie) |
| Study objectives | 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. |
| Ethics approval(s) | Approved by the Medical Ethical Committee UMC Utrecht on the 13th October 2006 (ref: NL14149.041.06). |
| Health condition(s) or problem(s) studied | Adenoidectomy in children, common cold, upper respiratory tract infection, rhinosinusitis |
| Intervention | Adenoidectomy within six weeks versus watchful waiting. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Upper respiratory tract infection with or without fever (38°C or higher); this will be measured continuously by means of symptom diaries and daily temperature measurements. |
| Secondary outcome measures | 1. Acute otitis media and otitis media with effusion episodes, measured continuously by means of symptom diaries 2. Health related quality of life, measured at inclusion (0 months), 3 months, 12 months and 24 months follow-up 3. Cost-effectiveness, measured continuously by means of symptom diaries 4. Nasopharyngeal flora, investigated at inclusion (0 months), 3 months and 12 months follow-up 5. Exhaled nitric oxide, measured at inclusion (0 months), 3 months, 12 months and 24 months follow-up |
| Overall study start date | 01/04/2007 |
| Completion date | 01/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 6 Years |
| Sex | Not Specified |
| Target number of participants | 110 |
| Key inclusion criteria | Children aged 1 to 6 years selected for adenoidectomy primarily because of recurrent upper respiratory tract infections (common colds and rhinosinusitis). |
| Key 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. Downs syndrome 6. Craniofacial malformations (e.g. cleft lip or palate) |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 01/02/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht (UMCU)
Utrecht
3508 AB
Netherlands
3508 AB
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.umcutrecht.nl/zorg/#http://www.umcutrecht.nl/zorg/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Thesis results | results | 01/12/2012 | No | No | |
| Other publications | economic evaluation | 01/02/2013 | Yes | No |
