Study design, setting and period
Institutional based cross –sectional study was conducted in Amhara region at central Gondar zone public primary hospitals in Ethiopia from March to April, 2019. These hospitals were established recently in the last few years. They are providing preventive, promotive and curative health care services to the population in central Gondar zone of the region and serve as a referral centers for the local health centers in the area. These primary hospitals are found in five districts (Dembiya, Chilga, Wogera, Delgi, and East Belesa) in central Gondar zone of the region. They are 781, 780, 787, 832 and 867 km away from Addis Ababa, the capital city of Ethiopia towards the Northwest ,respectively. All hospitals have a total number of 341 health workers. The neonatal intensive care units of each hospital have five neonatal beds for neonatal admission and have three clinical staff (one physician and two clinical nurses) and one cleaner. More than three thousand neonates were admitted in these hospitals annually to get medical services.
Study population and sampling procedure
All neonates admitted to neonatal intensive care units in central Gondar Zone primary hospitals were included in the study. The sample size was determined by using single population proportion formula and the proportion was taken from the previous literature in Ethiopia. According to study conducted at Gondar University teaching hospital, the prevalence of neonatal sepsis was 69.7%(23). By considering 95% confidence interval (CI), 5% marginal error, and 5% non-response rate. Therefore the final minimum adequate sample size was 352.
The study participants included 352 mother-neonate pairs who were admitted to NICUs during the study period and consented to participate in the study. The study enrolled neonates from birth to 28 days of age. Neonates with sepsis admitted for two or more time during the study period were considered to be excluded to avoid double count. However, there were no such cases in this study. The study populations were neonates admitted and treated in NICUs of central Gondar zone public primary hospitals in Ethiopia. According to the data obtained from these hospitals in 2018, the annual number of neonates admitted in neonatal intensive care units (NICUs) of these hospitals was estimated to be 3000 i.e. on the average 375 neonates were estimated to be admitted during the study period. Systematic random sampling technique was used to select study subjects during the study period. In this study neonatal sepsis is asserted when a medical diagnose of the neonate is stated as ‘neonatal sepsis’ by the physician in the neonate’s medical record chart.
Data collection tool, measurements, and quality management
The tool was developed from different literatures to gather the desired information from the sample population. The questionnaire was initially prepared in English language and translated in to Amharic (local language) and again it was retranslated back to English language to check for any inconsistencies or distortions in the meaning of words and concepts. Two days training was given to five data collectors (clinical nurses, diploma) and two supervisors (BSc nurses) prior to the beginning of data collection. Data collectors collected the data from the mother or care giver of the neonates by using interviewer administered structured Amharic version questioner that contains detail questions comprising all the variables of the study. Admission diagnosis of neonates was taken from the diagnosis of physician in the unit.
The WHO IMNCI criteria were applied to assess babies for clinical sepsis. The IMNCI criteria uses the following clinical features to make a diagnosis of clinical neonatal sepsis: not feeding well, convulsions, drowsy or unconscious, movement only when stimulated or no movement at all, fast breathing (60 breaths per min), grunting severe chest in-drawing, raised temperature > 38 °C, hypothermia < 35.5 °C, central cyanosis or could be severe jaundice, severe abdominal distension or localizing signs of infection were diagnosed as having neonatal sepsis(35).
A retrospective review of the history was taken to find out if the neonate had the symptoms suggestive of neonatal sepsis since birth. A conclusion of clinical neonatal sepsis was ascertained if the baby had any one of the symptoms of sepsis listed in the IMNCI criteria and admitted in NICUs. Medical documents from the health units attended were also used to get information on presentation of the patient to the health units and the treatment received.
Data were checked for its completeness & accuracy during data collection. Close supervision of trained data collectors (five diploma nurses) was undertaken by the trained supervisors (two BSc nurses). The supervisor strictly supervised the data collection process and provided on-site advice and feedbacks to the data collectors on daily basis. Daily exchange of information between the principal investigator and supervisors was undertaken by telephone. The principal investigator had had regular onsite supervision of supervisors and data collectors on weekly basis.
Neonatal sepsis: Neonates presented with any one of the systemic manifestation of danger signs:- not feeding well, convulsions, drowsy or unconscious, movement only when stimulated or no movement at all, fast breathing (60 breaths per min), grunting severe chest in-drawing, raised temperature > 38 °C, hypothermia < 35.5 °C, central cyanosis or could be severe jaundice, severe abdominal distension or localizing signs of infection were diagnosed as having neonatal sepsis(35).
Early onset of sepsis: If sepsis is occurred from birth to 7 days of age.
Late onset of sepsis: If sepsis is occurred between 8 and 28 days of age(32)
Data management and analysis
Questionnaires were checked daily for completeness and accuracy. All data was double entered, cleaned, edited, coded and entered into EPI INFO version 7.0 and exported to SPSS version 20.0 for analysis by binary logistic regression model. Both bivariate and multivariable analysis was used to see the association of different variables. Categorical variables were summarized into percentages and proportions. The continuous variables were summarized into means, medians, standard deviation and ranges and the results were presented with tables and figures. The proportion of clinical neonatal sepsis was obtained by calculating the proportion of neonates with symptoms and signs of clinical neonatal sepsis out of the total number of neonates who were admitted in NICUs during the study period. Bivariate analysis was used to determine association between neonatal sepsis and various independent variables including maternal factors, neonatal factors, and service related factors. Continuous independent variables were categorized and associations established using Chi-squared tests. This was similarly done for categorical variables. Adjusted odds ratio with 95% confidence interval was used to measure the degree of association between variables. P-value of < 0.05 was considered as statistically significant during multivariable logistic regression.
The proposal was reviewed and approved by the institute review board (IRB) of University of Gondar Institute of Public Health College of Medicine and Health Science before the start of the study. Informed consent was also obtained from mothers. A neonate aged 0 to 28 days of age who met the selection criteria was enrolled in the study. A pretested interviewer administered questionnaire was used to obtain history, physical examination and evaluate factors associated with neonatal sepsis. These included maternal factors, neonatal factors and neonatal health care practices, and service related factors.