Status:
COMPLETED
Short-term Effects of Ventilation Tubes in Children With Chronic Otitis Media With Effusion
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
Danish Medical Association
Conditions:
Otitis Media With Effusion in Children
Quality of Life
Eligibility:
All Genders
1-4 years
Phase:
NA
Brief Summary
The goal of this clinical, randomized trial is to compare the sleeping patterns and quality of life of children with chronic otitis media with effusion (OME) with or without tympanic tubes insertion. ...
Detailed Description
Statement of intent Background Otitis media with effusion (OME) is a common condition in the population of young children in Denmark. Sixty percent of the Danish children will experience at least one...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06100159
Start Date
January 20 2017
End Date
August 30 2022
Last Update
October 25 2023
Active Locations (2)
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1
Ørelægerne Fredericia
Fredericia, Denmark, 7000
2
Peter Tingsgaard
Slagelse, Denmark