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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR968 |
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Date of registration:
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10/05/2007 |
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Primary sponsor: |
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Public title:
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Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections.
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Scientific title:
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Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections. - NOA (Nederlands Onderzoek Adenotomie) |
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Date of first enrolment:
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1/4/2007 |
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Target sample size:
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110 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=968 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Anne G.M.
Schilder |
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Address:
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University Medical Center Utrecht
Wilhelmina Children's Hospital
Department of Otorhinolaryngology
PO Box 85090
3508 AB
Utrecht
The Netherlands |
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Telephone:
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+31 (0)30 2504004 |
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Email:
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A.Schilder@umcutrecht.nl |
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Affiliation:
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Name:
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Anne G.M.
Schilder |
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Address:
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University Medical Center Utrecht
Wilhelmina Children's Hospital
Department of Otorhinolaryngology
PO Box 85090
3508 AB
Utrecht
The Netherlands |
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Telephone:
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+31 (0)30 2504004 |
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Email:
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A.Schilder@umcutrecht.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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)
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Children, Randomised study, Adenoidectomy, Upper respiratory tract infection, Common cold, Rhinosinusitis
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Intervention(s)
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Adenoidectomy within 6 weeks versus watchful waiting.
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Primary Outcome(s)
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Upper respiratory tract infection with or without fever (38°C or higher)
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Secondary Outcome(s)
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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
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Secondary ID(s)
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ISRCTN03720485
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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