OBJECTIVE: To determine whether treatment with dexamethasone and ceftriaxone for children with bacterial meningitis reduces the frequency of either sensorineural hearing loss or other neurologic sequelae. DESIGN: This was a prospective, multicentered, placebo-controlled clinical trial. Subjects were followed for 1 year. SETTING: The study was conducted in six children's hospitals located in Pittsburgh, Houston, Los Angeles, Chicago, Washington, D.C., and Columbus, Ohio. PATIENTS: Enrolled 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. INTERVENTIONS: Subjects 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 MEASURES: Hearing, development, and neurologic sequelae were assessed at the time of discharge and 6 weeks and 1 year later. MAIN RESULTS:One hundred forty-three patients (69 receiveddexamethasone 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. CONCLUSION: All 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.
RCT Entities:
OBJECTIVE: To determine whether treatment with dexamethasone and ceftriaxone for children with bacterial meningitis reduces the frequency of either sensorineural hearing loss or other neurologic sequelae. DESIGN: This was a prospective, multicentered, placebo-controlled clinical trial. Subjects were followed for 1 year. SETTING: The study was conducted in six children's hospitals located in Pittsburgh, Houston, Los Angeles, Chicago, Washington, D.C., and Columbus, Ohio. PATIENTS: Enrolled 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. INTERVENTIONS: Subjects 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 MEASURES: Hearing, development, and neurologic sequelae were assessed at the time of discharge and 6 weeks and 1 year later. MAIN RESULTS: One 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. CONCLUSION: All 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.
Authors: Tatiana Barichello; Ana Lucia B Santos; Geovana D Savi; Jaqueline S Generoso; Paola Otaran; Cleonice M Michelon; Amanda V Steckert; Francielle Mina; Clarissa M Comim; Felipe Dal-Pizzol; João Quevedo Journal: Metab Brain Dis Date: 2012-05-17 Impact factor: 3.584
Authors: Diederik van de Beek; Jeremy J Farrar; Jan de Gans; Nguyen Thi Hoang Mai; Elizabeth M Molyneux; Heikki Peltola; Tim E Peto; Irmeli Roine; Mathew Scarborough; Constance Schultsz; Guy E Thwaites; Phung Quoc Tuan; A H Zwinderman Journal: Lancet Neurol Date: 2010-02-03 Impact factor: 44.182