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      Trends in the incidence of possible severe bacterial infection and case fatality rates in rural communities in Sub-Saharan Africa, South Asia and Latin America, 2010–2013: a multicenter prospective cohort study

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          Abstract

          Background

          Possible severe bacterial infections (pSBI) continue to be a leading cause of global neonatal mortality annually. With the recent publications of simplified antibiotic regimens for treatment of pSBI where referral is not possible, it is important to know how and where to target these regimens, but data on the incidence and outcomes of pSBI are limited.

          Methods

          We used data prospectively collected at 7 rural community-based sites in 6 low and middle income countries participating in the NICHD Global Network’s Maternal and Newborn Health Registry, between January 1, 2010 and December 31, 2013. Participants included pregnant women and their live born neonates followed for 6 weeks after delivery and assessed for maternal and infant outcomes.

          Results

          In a cohort of 248,539 infants born alive between 2010 and 2013, 32,088 (13 %) neonates met symptomatic criteria for pSBI. The incidence of pSBI during the first 6 weeks of life varied 10 fold from 3 % (Zambia) to 36 % (Pakistan), and overall case fatality rates varied 8 fold from 5 % (Kenya) to 42 % (Zambia). Significant variations in incidence of pSBI during the study period, with proportions decreasing in 3 sites (Argentina, Kenya and Nagpur, India), remaining stable in 3 sites (Zambia, Guatemala, Belgaum, India) and increasing in 1 site (Pakistan), cannot be explained solely by changing rates of facility deliveries. Case fatality rates did not vary over time.

          Conclusions

          In a prospective population based registry with trained data collectors, there were wide variations in the incidence and case fatality of pSBI in rural communities and in trends over time. Regardless of these variations, the burden of pSBI is still high and strategies to implement timely diagnosis and treatment are still urgently needed to reduce neonatal mortality.

          Trial registration

          The study was registered at ClinicalTrials.gov ( NCT01073475).

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          Most cited references10

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          The Maternal and Newborn Health Registry Study of the Global Network for Women's and Children's Health Research.

          To implement a vital statistics registry system to register pregnant women and document birth outcomes in the Global Network for Women's and Children's Health Research sites in Asia, Africa, and Latin America. The Global Network sites began a prospective population-based pregnancy registry to identify all pregnant women and record pregnancy outcomes up to 42 days post-delivery in more than 100 defined low-resource geographic areas (clusters). Pregnant women were registered during pregnancy, with 42-day maternal and neonatal follow-up recorded-including care received during the pregnancy and postpartum periods. Recorded outcomes included stillbirth, neonatal mortality, and maternal mortality rates. In 2010, 72848 pregnant women were enrolled and 6-week follow-up was obtained for 97.8%. Across sites, 40.7%, 24.8%, and 34.5% of births occurred in a hospital, health center, and home setting, respectively. The mean neonatal mortality rate was 23 per 1000 live births, ranging from 8.2 to 48.5 per 1000 live births. The mean stillbirth rate ranged from 13.7 to 54.4 per 1000 births. The registry is an ongoing study to assess the impact of interventions and trends regarding pregnancy outcomes and measures of care to inform public health. ClinicalTrial.gov NCT01073475. Copyright © 2012 International Federation of Gynecology and Obstetrics. All rights reserved.
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            Simplified antibiotic regimens compared with injectable procaine benzylpenicillin plus gentamicin for treatment of neonates and young infants with clinical signs of possible serious bacterial infection when referral is not possible: a randomised, open-label, equivalence trial.

            WHO recommends hospital-based treatment for young infants aged 0-59 days with clinical signs of possible serious bacterial infection, but most families in resource-poor settings cannot accept referral. We aimed to assess whether use of simplified antibiotic regimens to treat young infants with clinical signs of severe infection was as efficacious as an injectable procaine benzylpenicillin-gentamicin combination for 7 days for situations in which hospital referral was not possible.
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              Safety and efficacy of alternative antibiotic regimens compared with 7 day injectable procaine benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible: a randomised, open-label, equivalence trial.

              Severe infections remain one of the main causes of neonatal deaths worldwide. Possible severe infection is diagnosed in young infants (aged 0-59 days) according to the presence of one or more clinical signs. The recommended treatment is hospital admission with 7-10 days of injectable antibiotic therapy. In low-income and middle-income countries, barriers to hospital care lead to delayed, inadequate, or no treatment for many young infants. We aimed to identify effective alternative antibiotic regimens to expand treatment options for situations where hospital admission is not possible.
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                Author and article information

                Contributors
                phibberd@mgh.harvard.edu
                Journal
                Reprod Health
                Reprod Health
                Reproductive Health
                BioMed Central (London )
                1742-4755
                24 May 2016
                24 May 2016
                2016
                : 13
                : 65
                Affiliations
                [ ]Massachusetts General Hospital for Children, Boston, MA USA
                [ ]RTI International, Research Triangle Park, North Carolina, USA
                [ ]Jawaharlal Nehru Medical College, Belgaum, India
                [ ]Aga Khan University, Karachi, Pakistan
                [ ]Moi University, Eldoret, Kenya
                [ ]University of Zambia, Lusaka, Zambia
                [ ]Institute of Nutrition of Central America and Panama (INCAP), Guatemala City, Guatemala
                [ ]Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina
                [ ]Christiana Health Care, Newark, DE USA
                [ ]Columbia University, New York, NY USA
                [ ]Indiana University School of Medicine, Indianapolis, IN USA
                [ ]University of Alabama at Birmingham, Birmingham, AL USA
                [ ]University of Colorado Health Sciences Center, Denver, CO USA
                [ ]Tulane School of Public Health and Tropical Medicine, New Orleans, LA USA
                [ ]Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD USA
                [ ]Lata Medical Research Foundation, Nagpur, India
                Article
                177
                10.1186/s12978-016-0177-1
                4877736
                27221099
                435b2da9-8055-4c5e-9f4b-2f03e2ca5921
                © Hibberd et al. 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 11 December 2015
                : 5 May 2016
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000071, National Institute of Child Health and Human Development;
                Award ID: U10 HD078439
                Award Recipient :
                Categories
                Research
                Custom metadata
                © The Author(s) 2016

                Obstetrics & Gynecology
                neonatal sepsis,low middle income countries,possible severe bacterial infections,incidence of neonatal sepsis,case fatality rates from neonatal sepsis,global health

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