-
Randomized Controlled Trial Multicenter Study Clinical Trial
Dexamethasone therapy for children with bacterial meningitis. Meningitis Study Group.
- E R Wald, S L Kaplan, E O Mason, D Sabo, L Ross, M Arditi, B L Wiedermann, W Barson, K S Kim, and R Yogov.
- University of Pittsburgh School of Medicine, Pennsylvania, USA.
- Pediatrics. 1995 Jan 1;95(1):21-8.
ObjectiveTo determine whether treatment with dexamethasone and ceftriaxone for children with bacterial meningitis reduces the frequency of either sensorineural hearing loss or other neurologic sequelae.DesignThis was a prospective, multicentered, placebo-controlled clinical trial. Subjects were followed for 1 year.SettingThe study was conducted in six children's hospitals located in Pittsburgh, Houston, Los Angeles, Chicago, Washington, D.C., and Columbus, Ohio.PatientsEnrolled were 173 children, 8 weeks to 12 years of age, with suspected bacterial meningitis; 143 children were evaluable. Eighty-seven percent of patients were followed for at least 6 weeks to 3 months, and 67% were followed for 1 year.InterventionsSubjects were randomized to receive ceftriaxone with or without dexamethasone (0.15 mg/kg every 6 hours for 4 days). Auditory brainstem responses (ABR) were measured within 24 hours of admission.Main Outcome MeasuresHearing, development, and neurologic sequelae were assessed at the time of discharge and 6 weeks and 1 year later.Main ResultsOne hundred forty-three patients (69 received dexamethasone and 74 received placebo) with bacterial meningitis were evaluable: Haemophilus influenzae type b (83), Streptococcus pneumoniae (33), Neisseria meningitidis (24), and three others. Overall, there was no significant difference in auditory outcome between dexamethasone and placebo recipients. Twenty-two children had bilateral moderate or more severe hearing loss at the time of the first ABR. At follow-up, the resolution of hearing impairment was nearly identical for each group. Nine of ten children who remained persistently deaf were deaf at the time of the first ABR. There were no differences in neurologic or developmental outcome between groups.ConclusionAll but one child with persistent bilateral moderate or more severe hearing loss had demonstrable deafness at the time of the first ABR. Dexamethasone did not significantly improve audiologic, neurologic, or developmental outcome in children with bacterial meningitis.
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