Objective: To determine whether early routine grommet insertion in children with cleft palate has a beneficial effect on hearing and speech and language development compared with conservative management.
Design: Systematic review of randomized controlled trials, controlled clinical trials, case series, and prospective and historical cohort studies.
Main outcome measures: The main outcome measure was the effect of early routine grommet placement on the degree of conductive hearing loss. Secondary outcome measures included differences in hearing level, possible side effects, speech and language development, and quality of life.
Results: We identified 368 citations for review. From a review of the titles, 34 potentially relevant papers were selected. Of these, 18 studies met our inclusion criteria, including eight case series, six historical cohort studies, three prospective cohort studies, and one randomized trial. Most studies were either small or of poor quality or both. The results of the studies were contradictory, with some studies suggesting early placement of grommets was beneficial and others reporting there was no benefit.
Conclusions: There is currently insufficient evidence on which to base the clinical practice of early routine grommet placement in children with cleft palate.