Is gastro-oesophageal reflux related to otitis media in cleft palate?
Research type
Research Study
Full title
Investigating the presence of gastroesophageal reflux in children with cleft palate experiencing otitis media
IRAS ID
145315
Contact name
Per Hall
Contact email
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
Otitis Media with Effusion (OME) is the most common cause of childhood hearing loss. It is particularly common in children with cleft palate (possibly due to their palatal anatomical variation), and is currently treated with the insertion of grommets at the time of cleft palate repair in those with a failed hearing test. Gastro-oesophageal reflux has been postulated to be involved in the pathogenesis of OME, as several studies have shown the presence of pepsin in the middle ear effusions of non-cleft children. However, no studies have been performed on our patient group.
The aim of this study is to establish the levels of pepsin in the middle ear aspirates of affected children with cleft palate, collected at the time of grommet insertion. In addition we will correlate these levels with the width of their palatal cleft (the degree of their anatomical variation), and their breast-feeding history.
Currently there is a lack of evidence for the best treatment of OME in children with cleft palate, and the NICE Guideline Development Group recommended in 2008 that studies should evaluate the "acceptability, effectiveness, and consequences of the various treatment strategies for OME in children with cleft palate." Finding an alternative to surgical treatment would be attractive as almost 30% of patients require intervention for hearing loss (either grommet insertion or hearing aids), and of those with grommet insertion, 25% develop complications including tympanosclerosis, persistent ear drum perforation, ear pain, or retraction pockets. If a pathogenic link to gastro-oesophageal reflux can be established, there will be a rationale to trial pharmacological therapies directed at minimising this. This may in turn reduce the incidence of OME requiring surgical intervention.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
15/WM/0173
Date of REC Opinion
12 May 2015
REC opinion
Favourable Opinion