1.1. GB1] ]. Neonatal mortality rate is

1.1.      PROBLEM STATEMENTSepsis represents a significant public health problem and it is an important cause of morbidity and mortality in hospitalized patients 14.

The number of new born at risk of acquiring nosocomial infections is increasing because of the improved survival of very low birth weight infants and their need for invasive monitoring and supportive care 15,16. This assessment seems to be confirmed with service of neonatology that was recently developed at most of referral hospitals in Butembo.In sub-Saharan countries, sepsis is an important cause of illness and death in new-borns, the mortality rate approaches 53% which makes it a significant health problem in developing countries 9,15. Despite substantial progress, the world has not achieved the fourth goal of the Millennium Development Goal (MDG) which aimed to reduce child mortality by two thirds by 2015 Dr GB1 . Neonatal mortality rate is one of the indicators for measuring the health status of a nation 27,29. The latest report of the Demographic Health Survey in the Democratic Republic of the Congo (DRC) showed that for every 1,000 children born, 58 died before their first birthday (28 deaths between age 0 and 1 month) Dr GB2 . The 2015 report on maternal and newborn disparities country profile showed that neonatal sepsis mortality rate per 1,000 live births was 30. Sepsis counted 16% of all causes on neonatal deaths behind prematurity (34.

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7%) and birth asphyxia and trauma (28.6%) respectively Dr GB3 .The neonatal sepsis and antibiotic resistance in sepsis have heavy consequences. It leads to a high morbidity and mortality 3 and long term neurodevelopment delays and damage Dr GB4 . Consequently, hospitalization stay will be longer, and families and health care systems will incur additional costs ( Dr GB5 ).In sub-Saharan Africa, surveillance is not readily done.

And as evidenced by the scarcity of data regarding etiology, antimicrobial sensitivity patterns, insufficient knowledge about appropriate antibiotic choice, has led to development of guidelines based on data from the developed countries. This has posed a challenge in adequate management of neonatal sepsis in this region Dr GB6 .In the DRC, Mshana et al. reported that there is an increasing trend in the incidence of antibiotic resistance 17. Most of those pathogens are Multi-Drug-Resistant (MDR), i.

e. Staphylococcus aureus, Escherichia coli, Klebsiella pneumonia, Vibrio cholera, non-typhoid Salmonella and other pathogens responsible for nosocomial infections 18-21. Meanwhile, there is no available data on organisms causing neonatal sepsis and their susceptibility pattern in DRC; whereas physicians depend on reliable information on the local epidemiology of infection and antibiotic resistance rates to guide empiric treatment in critically patients 22-26. Thus, clinical microbiology services need to be strengthened in order to allow a coordinated surveillance for antimicrobial resistance and provide data for local guidelines and for national policies to control antimicrobial resistance 27,28. Periodic evaluation of organisms responsible of neonatal sepsis is essential for the appropriate management of neonates 29,26,30. Therefore, this study will be undertaken in order to isolate germs incriminated in neonatal sepsis and their antimicrobial patterns. This may help for initiation of empiric antibiotherapy.

The clinical diagnosis of sepsis in the neonate is difficult because many of the signs of sepsis are non-specific and can be observed with other noninfectious conditions. Although a normal physical examination may show evidence that sepsis is not present, bacteremia can occur in the absence of clinical signs. Available diagnostic testings are not helpful in deciding which neonate requires empirical antimicrobial therapy but can assist with the decision to discontinue treatment Dr GB7 . Therefore, an early diagnostic test stool that is highly sensitive with good negative predictive value near 100% for neonatal sepsis is needed and the determination of causative organism as well as their antimicrobial susceptibility pattern. 1.2.

      OBJECTIVE 1.2.1.     General objectiveThis study aims to determine the bacteriological profile and antimicrobial susceptibility pattern of neonates with sepsis in Butembo, Democratic Republic of the Congo.1.2.2.     Specific objectives-         Determine the prevalence, associated risk factors, evolution and outcome of neonatal sepsis in Butembo,-         Determine the bacteria responsible of neonatal sepsis and their antimicrobial susceptibility pattern,-         Compare the antimicrobial susceptibility pattern of isolates from neonates with sepsis with current antibiotic recommendations,-         Assess the occurrence of multidrug resistant bacteria in neonatal sepsis,-         Assess the value of inflammatory biomarkers for the diagnosis of neonatal sepsis,-         Develop a predictive score for neonatal sepsis diagnosis.

1.3.      JUSTIFICATION AND RELEVANCE OF THE STUDYBloodstream infections in neonates are life-threatening emergencies.

Delays in diagnosis and treatment with appropriate antibiotics may have devastating consequences. Identification of the common bacteria causing such infections and their susceptibility patterns will provide necessary information for timely intervention. Longitudinal surveillance should be carried out at regular intervals to describe the varied pathogens causing neonatal sepsis as well as their changing antibiotic susceptibility pattern and evaluating if the current antibiotic recommendations match with the susceptibility pattern of implicated organism. The early diagnosis of sepsis still remains a challenge to scientist and clinicians since no definite diagnostic tool is yet available. The lack of definitive diagnosis and the fear of missing a case of neonatal sepsis with its serious outcomes further lead to irrational use of antibiotics and may lead to the emergence of resistant strains.The use of blood culture and the measurement of biomarkers associated to risk factors represent potentially new predictive diagnostic tools for the early diagnosis of neonatal sepsis.

The combination of these biomarkers using a bioscore model will thus aid in the early diagnosis of sepsis. Although the use of biomarkers in helping diagnose sepsis has be explored and found to be promising, there is paucity of data regarding the use of biomarkers in diagnosing neonatal sepsis in DRC since most of such studies were carried out in developed countries. Therefore, there is a need for such studies in DRC. Developing the reliable predictive score in diagnosis of neonatal sepsis will help promoting the treatment strategies and avoiding the misuse of antibiotic.The findings of this study will help health program implementers and decision makers as a reference in order to cover up the matter as a source of literature when establishing the local guideline for neonatal sepsis therapy. Apart from that, this study will also help in informing timely and accurately empiric decisions in absence of blood cultures that may not be feasible in some situations, thereby reducing the risk of under treatment or over treatment of infections, both of which are associated with emergence and increasing of resistance to antibiotics.

 Dr GB1Milleniun Development Goal 4/UNDP Internet. Available from: http://www.undp.org/content/undp/en/home/mdgoverview/mdg_goals/mdg4/  Dr GB2Demographic Health Survey.

DRC Demographic Health Survey  2013-2014, Key findings. DHS, 2014.  Dr GB3UNICEF. Maternal and newborn disparities, Democratic Republic of Congo.

Key facts. 2015 Dr GB4 Dr GB5Obiero, C. W.

, Seale, A. C., & Berkley, J. a. (2015). Empiric treatment of neonatal sepsis in developing countries. The Pediatric Infectious Disease Journal, 34(6), 659–61.  Dr GB6Lubell Y, Ashley EA, Turner C, Turner P, White NJ.

Susceptibility of community-acquired pathogens to antibiotics in Africa and Asia in neonates–an alarmingly short review. Trop Med Int Health. 2011;16(2):145–51.  Dr GB7Edmond K, Zaidi A. New approaches to preventing, diagnosis, and treating neonatal sepsis.

PLoS medicine 2010;7(3). E1000213. DOI: 10.1371/journal.pmed.1000123.



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