ISRCTN04973569
Completed
Not Applicable
The effectiveness of adenotonsillectomy in children NATAN project: Nederlands AdenoTonsillectomie project, Tonsillectomy & Adenoidectomy in the Netherlands
niversity Medical Centre Utrecht (UMCU) (Netherlands)0 sites300 target enrollmentStarted: May 2, 2007Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- niversity Medical Centre Utrecht (UMCU) (Netherlands)
- Enrollment
- 300
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Children aged 2 to 8 years indicated for adenotonsillectomy according to current medical practice. These included children with recurrent throat infections (three or more episodes per year) or other indications such as obstructive complaints or recurrent upper respiratory infections.
Exclusion Criteria
- •Children with:
- •1\. A history of seven or more throat infections in the preceding year, or five or more in each of the two preceding years, or three or more in each of the three preceding years (Paradise criteria)
- •2\. High suspicion of obstructive sleep apnoea, i.e. Brouillette's Obstructive Sleep Apnoea (OSA) score of more than 3\.5
- •3\. Down's syndrome
- •4\. Craniofacial malformation, such as cleft palate
- •5\. Documented immunodeficiency, other than Immunoglobulin A (IgA) or Immunoglobulin G subclass two (IgG2\) deficiencies
Investigators
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