Prevalence and factors associated with neonatal sepsis at Kamuzu Central Hospital, Lilongwe, Malawi. Study protocol
| dc.contributor.author | Phiri, Wyness | |
| dc.date.accessioned | 2021-12-20T16:20:13Z | |
| dc.date.available | 2021-12-20T16:20:13Z | |
| dc.date.issued | 16-06-21 | |
| dc.description.abstract | This is an analytical cross-sectional study that aims to determine prevalence and factors associated with neonatal sepsis at Kamuzu Central Hospital. Problem to be studied Several factors are known to be associated with neonatal sepsis. Despite this, studies that have been conducted in Malawi have focused mainly on causative organisms. Understanding specific factors that are associated with neonatal sepsis is crucial in the prevention and management of neonatal sepsis. Therefore, this study aims at determining neonatal and maternal factors that are associated with neonatal sepsis at KCH in Lilongwe, Malawi. Objectives The study aims to determine factors associated with neonatal sepsis at KCH, Lilongwe Malawi. specifically, to determine the prevalence of neonatal sepsis to determine maternal factors associated with neonatal sepsis, and to determine neonatal factors associated with neonatal sepsis. Methodology We will use secondary data which will be extracted from the case notes. Neonates who were admitted from 1st January to 31st March 2021 will be included in the study. Neonates whose admission and discharge outcome data was captured by Neo-Tree bed-side tablet will be eligible for this study. Simple random sampling will be used to select participants of this study. The study will require a sample size of 380 participants to achieve a power of 80% at a 95% confidence interval. Collected data will be entered and cleaned in Microsoft excel then analyzed in Stata 16.0 to come up with odds ratios. Univariate and multivariate analysis will be done to identify statistically significant factors associated with neonatal sepsis. Expected findings and their dissemination It is expected that neonatal sepsis is associated with preventable risk factors. This study will add knowledge on the risk factors associated with neonatal sepsis which will help in coming up with evidence-based institutional interventions which will aim at reducing neonatal morbidity and mortality. The findings will be disseminated with Kamuzu Central Hospital, Reproductive Health Unit, College of Medicine library, and College of Medicine Research Ethics Committee (COMREC). 3.0 Background information and introduction The neonatal period is defined as the first 28 days of the life of a child. It is the most critical stage of life. Recent reports in 2019 show that 2.4 million children died in the first month of life globally. Sub-Saharan Africa and South Asia contributed to the highest neonatal mortality of 27 and 25 deaths per 1000 live births respectively [1] Recent reports of 2019 show that neonatal mortality for Malawi was at 19.8 deaths per 1000 live births [2]. Neonatal mortality is attributed to three major conditions which are preventable and treatable; Prematurity, intrapartum-related complications like birth asphyxia, and neonatal infections. These three major conditions account for 80% of neonatal deaths. [3] Neonatal sepsis is defined as a clinical syndrome characterized by signs and symptoms of infection in neonates from day 1 of life to 28 days [4]. Neonatal sepsis is divided into two; early- onset which occurs in the first 72 hours of life and late-onset which occurs after 3 to 7 days of life. The most critical one which contributes more to neonatal mortality is the early onset [5]. For a systematic review and a meta-analysis which was conducted, a pooled neonatal sepsis incidence from 26 studies of 2824 neonatal sepsis cases per 100 000 live births was estimated [6]. Neonatal sepsis attributes to 17% of neonatal deaths in Sub-Saharan Africa (SSA) [7]. Despite neonatal sepsis deaths surpassing that of HIV in neonates, neonatal sepsis does not receive much funding as a public health priority worldwide. Neonatal sepsis accounts for an annual economic burden ranging from 10 billion to 469 billion US dollars in SSA [8]. Several pathogens cause neonatal sepsis. Studies that have been conducted in developed countries have reported that group B streptococcus (GBS) is the commonest cause of neonatal sepsis. In developing countries, Gram-negative bacteria is the commonest cause contrary to developed countries. [13] Clinical signs are used to come up with the diagnosis of neonatal sepsis using the Integrated management of childhood illnesses (IMCI) guideline by WHO in developing countries including Malawi [14]. The presence of two or more of the following signs are signals neonatal sepsis; a core temperature of greater than 38.5 degrees Celsius or less than 36 degrees’ Celsius convulsions, bradycardia or tachycardia, lethargy, respiratory distress, apnoea, poor reflexes, abdominal distension, and bleeding [15] [16]. Several studies have been conducted in India [18], Ghana [19] [20], Nigeria [21], Ethiopia [22] [23], and Tanzania [24] [25] to identify maternal and neonatal risk factors associated with neonatal sepsis. Key maternal risk factors associated with neonatal sepsis were premature rupture of membranes (PROM) [18] [23] [25], maternal age [18] [7] [25], and place of delivery [21] [18] [25] while neonatal risk factors were neonatal age [18] [19] [20] [22] [4] [24], use of oxygen via 16-Jun-2021 Prevalence and factors associated with neonatal sepsis at Kamuzu Central Hospital, Lilongwe, Malawi. Study protocol, v 1.0. 13/04/2021 version 2.0 P. 04/21/3310 - 26/05/2021 13 Mask [22] [18] [24], birth weight 20] [23], APGAR score [19] [24], and resuscitation at birth [19] [24]. Curiously, neonatal sepsis was not associated with gestation age [20] [22] [23] [25], antenatal care services [4] [19] [22] [23], and urinary tract infection [14] [19] [22]. A study in Nigeria investigated association of neonatal sepsis with change in antibiotics, and number of switches in antibiotics which were statistically significant factors [21]. These factor has not been investigated in most of studies conducted in Africa. Neonatal sepsis is managed by the administration of broad-spectrum antibiotics, fluids, vasoactive, and/or inotropic support [16]. In developing countries, neonatal sepsis is managed in line with IMCI guidelines as follows; hospitalization of the neonate with rapid administration of antibiotics either intravenously or intramuscularly, a combination of gentamicin and benzylpenicillin or ampicillin for 7-10 days [17]. Efforts have been put in place to achieve the Sustainable Development Goal (SDG) number 3 which aims at ending preventable deaths in neonates and under-fives. Thermal protection by skin to skin contact between a mother and the neonate, hygienic umbilical cord and skin care, early and exclusive breastfeeding, assessment of danger signs, and preventive treatment like immunization with BCG and vitamin K prophylaxis are some of the essential newborn care strategies to improve child survival and wellbeing [9]. However, with the current trends, it is reported that more than 60 countries will not be able to achieve the neonatal mortality target of at least less than 12 deaths per 1000 live births by 2030[10]. The government of Malawi in collaboration with USAID works to prevent neonatal and maternal deaths by integrating evidence-based activities in activities that address vital maternal, neonatal, and child health at households, community, and facility levels. At the facility level, they have provided Basic Emergency Obstetric and Newborn Care (BEMONC) life-saving signal interventions in some districts, the orientation of health workers on Kangaroo Mother Care (KMC), provision of Bubble Continuous Positive Airway Pressure mentorship to health workers through MOH Acute Respiratory Infections Programs and distribution of Maternal Newborn Child Health (MNCH) equipment and supplies [11] In 2015, Every Newborn Action Plan was launched in Malawi to guide the efforts of the Ministry of Health, district officers, and all stakeholders to design specific plans for accelerating progress toward ending preventable deaths among mothers and newborns and avoidable stillbirth. The plan calls for the provision of a skilled attendant at every birth, community involvement in maternal and neonatal care, and strengthening facilities that provide basic emergency obstetric and neonatal care and comprehensive emergency obstetric and neonatal care. [12] 16-Jun-2021 Prevalence and factors associated with neonatal sepsis at Kamuzu Central Hospital, Lilongwe, Malawi. Study protocol, v 1.0. 13/04/2021 version 2.0 P. 04/21/3310 - 26/05/2021 14 4.0 Rationale/ justification for the research project To achieve the sustainable development goal number 3 by 2030 which aims to end preventable deaths of new-born and children under five years of age, there is a need to come up with strategies to reduce these neonatal deaths. Since neonatal sepsis is one of the major causes of neonatal morbidity and mortality, determining factors that are associated with neonatal sepsis at KCH will help in the early identification of neonates at risk of neonatal sepsis and coming up with an evidence-based institutional intervention that may help in reducing neonatal morbidity and mortality. The studies that have been conducted in Malawi have focused on the causative organisms [13] [26]. There is limited scientific knowledge on the factors that are associated with neonatal sepsis in Malawi. Although studies have been conducted in other African countries, findings cannot be applied in Malawi settings due to differences in health systems building blocks that exist among countries; leadership and governance, health care financing, health workforce, medical products and technologies, information and research, and service delivery. Therefore, this study will determine factors that are associated with neonatal sepsis in Malawi. The study will determine associations between maternal age, PROM, place of delivery, neonatal age, use of oxygen via face masks, birth weight, APGAR score, and resuscitation at birth which are statistically associated with neonatal sepsis in studies that have been conducted. The study will also determine associations between intravenous cannulation [24], immediate and exclusive breastfeeding [4], mode of feeding, and neonatal sepsis because few studies have assessed their associations with neonatal sepsis. 4.0 Objectives of the study 5.1 Broad objective To determine prevalence and factors associated with neonatal sepsis at KCH from 1st January 2021 to 31st March 2021 5.1.1 specific objectives To determine the proportion of neonates with neonatal sepsis To assessdetermine maternal factors associated with neonatal sepsis To identifydetermine neonatal factors associated with neonatal sepsis 1 1Maternal age, premature rupture of membranes(PROM), place of delivery, mode of delivery, age 16-Jun-2021 Prevalence and factors associated with neonatal sepsis at Kamuzu Central Hospital, Lilongwe, Malawi. Study protocol, v 1.0. 13/04/2021 version 2.0 P. 04/21/3310 - 26/05/2021 16 of a neonate on admission, birth weight, resuscitation at birth, oxygen administration via face mask, time of initiation of breastfeeding, mode of feeding, APGAR score at one minute and five minutes, intravenous cannulation, and duration of staying in the hospital. 16-Jun-2021 Prevalence and factors associated with neonatal sepsis at Kamuzu Central Hospital, Lilongwe, Malawi. Study protocol, v 1.0. 13/04/2021 version 2.0 P. 04/21/3310 - 26/05/2021 17 6.0 Methodology 6.1 Type of the study This is an analytical cross-sectional study that aims to determine factors associated with neonatal sepsis. 6.2 Study place The study will be conducted at KCH; Ethel Mutharika Nursery in Lilongwe, Malawi. It is located in the central region of Malawi. KCH has been chosen as a study site because it is a tertiary hospital with good diagnostic equipment to diagnosis neonatal sepsis. It also has specialist and consultants who are experts in giving definite diagnosis neonatal sepsis. Since all the facilities in Lilongwe and surrounding districts do not have the capacity to diagnose and manage neonatal sepsis, cases are referred to KCH. Lilongwe has a population of 1,170,870. Ethel Mutharika nursery is a referral facility that admits sick babies from the northern and central regions of Malawi. The facility admits 250 babies per month on average. The facility admits neonates with prematurity, birth asphyxia, neonatal sepsis, pneumonia, prematurity with respiratory distress syndrome, low birth weight, jaundice, congenital abnormalities, gastroschisis, meconium aspiration, and others which are categorized as other conditions. Consultants and specialists help in the management of patients at this facility. It has a bed capacity of about 100. The hospital uses Neo-Tree electronic system data capture to document admissions and outcome data. The Neo-Tree is a bedside digital tablet with an electronic admission form that was developed based on the facility guidelines. In between admission and discharge, care given to patients is documented manually in the case files. All the printouts from the Neo-Tree are attached to the patient's file. 6.3 Study population All neonates who were admitted from 1st January 2021 to 31st March 2021 at the Ethel Mutharika nursery unit will be the study population for this study. This period is when Neo-Tree came into effect at KCH. The system minimizes human errors during data collection. The following is the inclusion criteria; 1. Neonates admitted between 1st January 2021 to 31st March 2021 2. Case notes which data was captured by Neo-Tree on admission The following is the exclusion criteria; 1. Neonates admitted out of the study period 2. Case notes which data was not captured by Neo-Tree on admission 16-Jun-2021 Prevalence and factors associated with neonatal sepsis at Kamuzu Central Hospital, Lilongwe, Malawi. Study protocol, v 1.0. 13/04/2021 version 2.0 P. 04/21/3310 - 26/05/2021 | en_US |
| dc.description.sponsorship | Self Sponsored | en_US |
| dc.identifier.uri | http://rscarchive.kuhes.ac.mw/handle/20.500.12988/592 | |
| dc.language.iso | en | en_US |
| dc.publisher | Kamuzu University Of Health Sciencies | en_US |
| dc.title | Prevalence and factors associated with neonatal sepsis at Kamuzu Central Hospital, Lilongwe, Malawi. Study protocol | en_US |