orofacial cleft with secretory otitis media
Conditions
Interventions
half year group:Tympanostomy tube implantation for half a year
one year group:Tympanostomy tube implantation for a year
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
1 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1) Children with unilateral complete cleft lip and palate (Veau classification III). 2) The age of initial diagnosis was less than 18 months, and the cleft lip and palate were repaired for the first time within 12-18 months. 3) Recurrent acute secretory otitis media (3 or more in 6 months or 4 or more in 1 year) or persistent secretory otitis media (with a duration of more than 3 months and conductive hearing loss of more than 25 dB). 4) Auditory examination showed conductive hearing loss of more than 30 dB in children. 5) No history of tympanic membrane perforation, excluding upper respiratory tract infection and sinusitis. 6) No operative contraindication. 7) agree to participate in the test and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Syndromic diseases with cleft lip and palate. 2) Simple cleft lip without cleft palat. 3) Paitents with a history of surgery before the first visit in our hospital. 4) Hearing loss caused by other diseases, trauma, genetic factors, drug damage and noise. 5) Children who have received hearing aids before their first visit. 6) Children and their family members who refuse tympanic catheterization and fail to cooperate with regular follow-up after operation. 7) Patients with cardiopulmonary disease and intolerance to surgery. 8) Complicated with other chronic diseases. 9) Patients or their families who have unrealistic expectations of subjects or guardians regarding the benefits, risks and limitations associated with surgical procedures and therapeutic instruments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| auditory brainstem response ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pure tone audiometry;acoustic immitance;articulation of speech; | — |
Countries
China
Contacts
Public ContactZhihua Zhang
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed