Glue Ear Clinical Trial
Official title:
Balloon Dilation of the Eustachian Tube in Children: a Randomized Side-controlled Clinical Trial
Otitis media with effusion (OME) is very common in children and characterized by fluid in the
middle ear without signs or symptoms of acute ear infection. Treatment options are
tympanostomy tubes and/or adenoidectomy. However OME often reoccurs after these procedures.
Goal of this study will be to evaluate the Balloon Eustachian Tuboplasty (BET) in children as
an additional treatment option and to assess long-term effects of BET. Beside the standard
procedure, children (4 to 10 years of age), with equal pathology on both ears, will be
assigned for BET on side.
Introduction:
Otitis media with effusion (OME, "glue ear") is very common in children and characterized by
fluid in the middle ear without signs or symptoms of acute ear infection. Fluid in the middle
ear causes conducting hearing loss. OME has a large impact on health care costs and recurrent
or persistent OME can effect the proper development of children. Frequently OME resolves
itself, therefore guidelines strongly recommend watchful waiting for 3 months after which
treatment options are tympanostomy tubes and/or adenoidectomy. However OME often reoccurs
after these procedures. Furthermore there are various short and longterm side-effects of
tympanostomy tubes.In Balloon Eustachian Tuboplasty (BET) a ballon catheter is used to dilate
the cartilage part of the eustachian tube and is inserted through the nose to reach the
opening of the tube, located in the nasopharynx. BET has recently been applied in children
for therapy-resistant recurrent OME and inflammatory ear diseases with promising results.
Risk and complications rates are very low.
Methods:
Goal of this study will be the evaluation of Balloon Eustachian Tuboplasty (BET) in children
as a primary treatment of OME. Children between the ages of 4 and 10 years with OME and
tympanometry type B on both ears, will prospectively be recruited and assigned for
adenoidectomy and myringotomy. Parents then will be asked for participation in this trial and
fully informed about purpose, technique and possible side effects. If consent is given,
adenoidectomy, in case of large adenoids, and myringotomy will be performed on both sides. If
necessary (very thick fluid) tympanostomy tubes are placed. One Eustachian tube of each
patient is randomly assigned for BET.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03868891 -
Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate
|
N/A |