Contact information
Type
Scientific
Primary contact
Dr Anne G.M. Schilder
ORCID ID
Contact details
University Medical Centre Utrecht (UMCU)
Wilhelmina Children's Hospital
Department of Otorhinolaryngology
P.O. Box 85090
Utrecht
3508 AB
Netherlands
+31 (0)30 250 4004
A.Schilder@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
NOA (Nederlands Onderzoek Adenotomie)
Study 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.
Ethics approval
Approved by the Medical Ethical Committee UMC Utrecht on the 13th October 2006 (ref: NL14149.041.06).
Study design
Randomised, multicentre, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Adenoidectomy in children, common cold, upper respiratory tract infection, rhinosinusitis
Intervention
Adenoidectomy within six weeks versus watchful waiting.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/04/2007
Overall trial end date
01/02/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Children aged 1 to 6 years selected for adenoidectomy primarily because of recurrent upper respiratory tract infections (common colds and rhinosinusitis).
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
110
Participant 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)
Recruitment start date
01/04/2007
Recruitment end date
01/02/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Utrecht (UMCU)
Utrecht
3508 AB
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (The Netherlands)
Sponsor details
P.O. Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
Hospital/treatment centre
Website
http://www.umcutrecht.nl/zorg/#http://www.umcutrecht.nl/zorg/
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22394446
2. 2013 economic evaluation in http://www.ncbi.nlm.nih.gov/pubmed/23329006
Publication citations
-
Economic evaluation
Boonacker CW, van den Aardweg MT, Broos PH, Hoes AW, Schilder AG, Rovers MM, Immediate adenoidectomy vs initial watchful waiting strategy in children with recurrent upper respiratory tract infections: an economic evaluation., JAMA Otolaryngol Head Neck Surg, 2013, 139, 2, 129-133, doi: 10.1001/jamaoto.2013.1324.