Hypothesis and aims: The specific aims of the research are to determine whether newborn ears with persistent middle ear effusion at age 30 to 48 hours are more likely to develop chronic otitis media with effusion over the first year of life when compared with ears without persistent middle ear effusion. The hypothesis is that neonates with middle ear effusion persisting to 30 to 48 hours are more likely to develop chronic otitis media with effusion.
Study design: Prospective, case-control design. Loupe-magnified pneumatic otoscopy performed at the time of newborn hearing screening determined presence or absence of effusion. Infants enrolled in the study returned for outpatient examinations.
Setting: University medical center well-baby nursery and out-patient audiology clinic.
Subjects: From 454 neonates, 14 experimental subjects with neonatal middle ear effusions and 15 control subjects free of neonatal effusion were recruited for the study and followed-up for 1 year.
Interventions: Outpatient study tests included transient-evoked otoacoustic emissions, tympanometry, pneumatic otoscopy, and visual reinforcement audiometry (starting at age 6 months), at 3, 6, 9, and 12 months of age. Experimental (neonatal effusion) infants were followed-up starting at age 1 month. Infants found at any follow-up examination to have effusion on otoscopy were followed-up and tested 1 month later.
Main outcome measures: Chronic otitis media with effusion defined as hypomobile or immobile tympanic membrane on pneumatic otoscopy in one or both ears for three consecutive monthly examinations. Hearing loss defined as greater than 25-dB hearing loss visual reinforcement audiometry thresholds.
Results: Eight experimental infants (58%) and three control infants (20%) developed chronic otitis media with effusion (p < 0.04). The average number of effusions was 1.27 for control and 4.14 for experimental infants (average number of effusions for each group at 3-, 6-, 9-, and 12-month visits). Warbled tone and speech visual reinforcement audiometry thresholds averaged 3 dB worse in the experimental group, but these differences were not statistically significant. For the control group, mean visual reinforcement audiometry thresholds never exceeded 25 dB hearing loss. For the experimental group, mean visual reinforcement audiometry thresholds exceeded 25 dB hearing loss at 1,000, 2,000, and 4,000 Hz at 9 months.
Conclusions: A majority of infants with persistent neonatal middle ear effusion found by pneumatic otoscopy at 30 to 48 hours will develop chronic otitis media with effusion during the first year of life. However, chronic otitis media with effusion is common in all infants (20% of controls), a time during which infants are examined and tested frequently.