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Risk Of Hearing Loss In Children Exposed To Gentamicin For The Treatment Of Sepsis In Young Infancy: A Community Based Cohort Study In Pakistan, Urooj Iftikhar, Syed Asad Ali, Shiyam Sunder Tikmani, Iqbal Azam, Sarah Saleem, Anita Kaniz Zaidi

Department of Paediatrics and Child Health

Objective: To determine the safety of gentamicin when used in a community setting to treat neonatal sepsis.
Methods: The study was conducted in peri-urban areas of Karachi from September 2009 to April 2010. The exposed group consisted of children 6 months to 3 years of age who were treated for sepsis during 0-2 months of age in the community, with a regimen that included gentamicin for at least five days.The control group included children from the same area who never received gentamicin. The outcome measure was hearing loss, which was assessed by Brainstem Evoked Response Audiometry.
Results: Of the 255 …

Scientific Rationale For Study Design Of Community-Based Simplified Antibiotic Therapy Trials In Newborns And Young Infants With Clinically Diagnosed Severe Infections Or Fast Breathing In South Asia And Sub-Saharan Africa., Anita K. M. Zaidi, Abdullah H. Baqui, Shamim Ahmad Qazi, Rajiv Bahl, Samir Saha, Adejumoke I. Ayede, Ebunoluwa A. Adejuyigbe, Cyril Engmann, Fabian Esamai, Antoinette Kitoto Tshefu, Robinson D. Wammanda, Adegoke G. Falade, Adetanwa Odebiyi, Peter Gisore, Adrien Lokangaka Longombe, William N. Ogala, Shiyam Sundar Tikmani, A. S. M. Nawshad Uddin Ahmed, Steve Wall, Neal Brandes, Daniel E. Roth, Gary L. Darmstadt

Paediatrics and Child Health, East Africa

Background: Newborns and young infants suffer high rates of infections in South Asia and sub-Saharan Africa. Timely access to appropriate antibiotic therapy is essential for reducing mortality. In an effort to develop community case management guidelines for young infants, 0–59 days old, with clinically diagnosed severe infections, or with fast breathing, 4 trials of simplified antibiotic therapy delivered in primary care clinics (Pakistan, Democratic Republic of Congo, Kenya and Nigeria) or at home (Bangladesh and Nigeria) are being conducted.

Methods: This article describes the scientific rationale for these trials, which share major elements of trial design. All the trials are …