Treatment of persistent middle ear effusion in cleft palate patients

The goals of the research project are to learn how to individualize otologic care for cleft palate patients and to be able to counsel families of children with cleft palate on the benefit of tympanostomy tubes, hearing issues and risks of multiple sets of tubes.

The study is a retrospective chart review. Patients with a cleft palate with or without a cleft lip born between 1 January 2000 and 31 December 2005 referred to the Connecticut Children's Medical Center Craniofacial Department were included in the study. The patients were offered individualized ear surgery (PE tube placement) only if persistent middle ear fluid was present for over 3 months with a conductive hearing impairment. The primary outcome measures included the newborn hearing screening results, number of ear tube surgeries, and complications of PE tube insertion.

There were 86 patients with cleft palate spectrum with or without cleft lip (45 females and 41 males). Twelve had undocumented newborn hearing evaluations. Of the 74 evaluable results, 61 (82%) passed the newborn hearing screening, 8 (11%) failed and 5 (7%) were inconclusive. By 5 years old, 84 (98%) patients received at least one set of ear tubes for persistent middle ear fluid with conductive hearing impairment, while 2 received no tubes (2%). Of those who received ear tubes, the range was 1-6 with a mean of 1.7. Twelve patients (14%) had tympanosclerosis. Eight patients (9%) had eardrum perforation. One patient had myringoincudopexy. Of the 86 patients, 12 had undocumented newborn hearing evaluations. Of the 74 evaluable results, 61 (82%) passed the newborn hearing screening, 8 (11%) failed and 5 (7%) were inconclusive.

(1) The majority of children born with cleft palate do not have middle ear fluid at birth. (2) Most children with cleft palate will likely develop persistent middle ear fluid with conductive hearing loss. Risks of complications from ear tubes in cleft palate patients are few and manageable using standard sized ear tubes.