Short-term Effects of Ventilation Tubes in Children With Chronic Otitis Media With Effusion
Otitis Media With Effusion in Children, Quality of Life, Sleep
About this trial
This is an interventional treatment trial for Otitis Media With Effusion in Children
Eligibility Criteria
Inclusion Criteria: Age 1-4 years with chronic otitis media with effusion and subjective hearing loss 1. time ventilation tube insertion At least three months with middle ear fluid in both ears before inclusion ASA group 1 and 2 Exclusion Criteria: Recurrent AOM Concomitant adenoidectomy or adenotonsillectomy Lip-gum-cleft anomalies or other craniofacial malformations Downs syndrome Existing sleep apnea Asthmatic bronchitis or other chronic lung diseases like CF or other sleep disorders ASA > 2 Children with hyperkinetic syndrome Present breastfeeding during night Not fluent in Danish language Other systemic diseases
Sites / Locations
- Ørelægerne Fredericia
- Peter Tingsgaard
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Tympanostomy tube
Control
Insertion of tympanostomy tubes after 3 months observation for chronic otitis media with effusion (OME) according to the National guidelines in Denmark. Sleep measurements with accelerometer 7 nights before and 7 nights after intervention. Caregivers report use of paracetamol during nights with sleep measurements.
No tympanostomy tube treatment up to 1 month after enrollment in control group. Sleep measurements with accelerometer 7 nights at time of inclusion. Caregivers report use of paracetamol during nights with sleep measurements. After 1 month tympanic tube insertion is allowed if still chronic OME. If tympanostomy tubes are needed the children will undergo same evaluation as the intervention group.