Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections

ISRCTN	ISRCTN03720485
DOI	https://doi.org/10.1186/ISRCTN03720485
Protocol serial number	N/A
Sponsor	University Medical Centre Utrecht (UMCU) (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

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

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
Email	A.Schilder@umcutrecht.nl

Study information

Primary study design	Interventional
Study design	Randomised, multicentre, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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
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 sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	economic evaluation	01/02/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Thesis results	results	01/12/2012		No	No