Bacterial neonatal sepsis,antimicrobial resistance,and risk factors among neonates in Ethiopia: a systematic review and meta-analysis

Abstract

Background:

Antimicrobial resistance and bacterial neonatal sepsis are major threats causing high morbidity and mortality among neonates in developing countries, including in Ethiopia. Given the lack of comprehensive and synthesized evidence on the magnitude of the bacterial profile, neonatal sepsis, and antimicrobial resistance among neonates, this systematic review and meta-analysis were initiated to address this gap.

Objective:

The aim of this meta-analysis aims to assess the prevalence, antimicrobial resistance patterns, and risk factors of neonatal sepsis in Ethiopian neonates.

Design:

Systematic review and meta-analysis were conducted among Ethiopian neonates.

Data source and methods:

Preferred reporting item for systematic review and meta-analysis (PRISMA) was used to screen the identified studies. We conducted a systematic search of various electronic databases including PubMed/MEDLINE, Cochrane Library, African Journals Online (AJOL), Web of Science, Grey literature and Google Scholar. The data were extracted in Microsoft Excel using a standardized data extraction format by two authors. The analysis was carried out with STATA version 17. To detect heterogeneity across studies, the I² and the Cochrane Q test statistics were computed. To determine the overall pooled prevalence, a random-effect meta-analysis model was used. This systematic review and meta-analysis were performed according to the updated guidelines, rigorous meta-analytical methodologies to ensure accuracy and reliability.

Results:

Of 9013 retrieved articles, 20 studies containing 11,754 neonates with a total of 3168 bacterial isolates (837 Gram-positive, 2328 Gram-negative). The predominant bacteria identified were: Klebsiella pneumoniae (1343), Escherichia coli (854), Staphylococcus aureus (356), other Klebsiella spp (234), CoNS (192), Acinetobacter species (172), GBS (164). The overall pooled prevalence of bacterial neonatal sepsis and multi-drug resistance (MDR) were 29.92% (25.79–34.05) and 66.20 (55.43–76.97). The subgroup analysis of this systematic review further revealed that the highest prevalence was observed in Oromia (31.62%) and Amhara (31.56%). The isolated bacteria were more resistant to penicillin groups, cephalosporins, and aminoglycosides. Preterm birth AOR = 8.2, 95%CI: 1.12–15.77), premature rupture of membranes (AOR = 4.8, 95%CI: 3.17–12.77), history of urinary tract infection at antenatal care (AOR = 33.21, 95%; 3.2–63.21), and low birth weight (AOR = 13.73, 95%CI: 4.48–31.95) were significantly associated with bacterial neonatal sepsis.

Conclusion:

Bacterial neonatal sepsis and MDR have been relatively high. Preterm birth, premature rupture of membranes, history of urinary tract infection at antenatal care, and low birth weight were significantly associated. Implementing antimicrobial stewardship and regular surveillance to control antimicrobial resistance is vital for informing region-specific antibiotic use. Furthermore, early diagnosis and proactive screening for risk factors are key to preventing neonatal sepsis and decreasing its overall burden.

Keywords

antimicrobial resistance bacteria Ethiopia neonates sepsis

Introduction

Bacterial neonatal sepsis, a bloodstream infection of different Gram-positive and negative bacteria which is a leading cause of newborn morbidities and deaths in developing countries, contributing significantly to both illness and mortality.¹ It continues to be a major challenge in neonatal medicine, along with preterm birth. Neonatal sepsis accounts for nearly 50% of all deaths worldwide among children **under the age of five.² Neonatal infections remains a major global problem, with recent estimates showing nearly 3.9 million cases and Internationally, in children under five deaths are caused by (22%) neonatal infections, (25%) complications during child birth and (34%) issues related to preterm birth.^3,4 Worldwide, neonatal sepsis is responsible for around 15% of deaths that occur during the neonatal period.⁵ Yearly, about 1.3 million cases of neonatal sepsis are documented globally in preterm and low birth weight leading to 203,000 mortalities.⁶ Sub-Saharan Africa bears nearly half of the world’s neonatal mortality burden, with approximately 8.75 million Disability-Adjusted Life Years (DALYs) lost each year due to neonatal sepsis.³ The morbidity of neonatal sepsis in East Africa was 29.76%⁷ and different pockets of studies in the Ethiopian regions were conducted to assess magnitude and associated factors of neonatal sepsis ranges from (23.8%–78.6%).^8–12 The burden of antimicrobial resistance (AMR) in neonatal sepsis is a critical concern, significantly impacting treatment outcomes and healthcare systems, becoming a catastrophic burden in managing cases among the neonate, especially in low- and middle-income countries.^13,14 The rise in multidrug-resistant (MDR) bacteria is particularly concerning in neonatal populations, limiting treatment options.¹⁵ Neonatal sepsis is categorized according to the age at which it occurs: early-onset sepsis (EOS) and late-onset sepsis (LOS).¹⁶ EOS happens within the first 72 h of life, whereas late-onset sepsis (LOS) occurs after that timeframe.^16,17 Several factors contribute to an increased risk of neonatal sepsis, which can significantly impact the health of newborns.^8,12,18 These factors can be categorized into maternal, neonatal, and environmental influences.⁸ Maternal influences include maternal fever, urinary tract infections (UTIs) during pregnancy, prolonged rupture of membranes (PROM), and being unmarried.¹⁹ Neonatal factors consist of low birth weight (LBW), prematurity, a low Apgar score, and environmental influences, such as the need for resuscitation at birth, medical interventions, and poor hygiene practices,^8,10,20 and the common bacterial profiles constantly changing in the neonates.²¹ The likelihood of neonatal sepsis is greater for infants born before 37 weeks of gestation.¹⁷ The impact of neonatal sepsis in Ethiopia is considerable, with fragmented evidence and complex issues, highlighting both healthcare obstacles and wider socio-economic issues, and also there is no consolidated data that elaborates on the problem of bacterial neonatal sepsis and AMR as a whole. As a result, the aim of this systematic and meta-analysis was to assess the bacterial neonatal sepsis, antimicrobial resistance, and risk factors among the neonates in Ethiopia.

Methods

The study was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA, 2020) guidelines²² (Supplemental File 1). This systematic review and meta-analysis was performed following revised, rigorous meta-analytical methodologies to ensure accuracy and reliability.

Search strategy: A comprehensive search across several databases, including CENTRAL (Cochrane Central Register of Controlled Trials), Embase via Ovid, PubMed, Web of Science, CINAHL (Cumulative Index to Nursing and Allied Health Literature), CLIB (The Cochrane Library), African Journals Online, Embase.com, LILACS (Latin American and Caribbean Health Sciences Literature), MEDLINE, Google, Google Scholar, and Open Grey were conducted. This search aimed to identify studies published between April 1, 2015, and June 30, 2025 (the date of our last search). We utilized keywords that combined aspects of population, condition/outcome, context, and exposures. Additionally, we performed a snowball search to explore references from relevant papers for related articles. For studies with incomplete data, we reached out to the corresponding authors. Included studies had to specifically focus on neonatal data (<1-year age) or present neonatal information that was clearly differentiated from other age groups. Neonatal sepsis was defined as the presence of bacteria with blood culture-proven sepsis in this age group within the context of Ethiopia. We searched each database using various combinations of the following MeSH terms: “neonate,” “infant,” “newborn,” “sepsis,” “bacterial sepsis,” “Gram-negative aerobic bacteria,” “Gram-negative bacteria,” “Gram-negative bacterial infections,” “Gram-positive bacteria,” “Gram-positive bacterial infection,” “septicaemia,” “bloodstream infection,” “microbial sensitivity tests,” “drug resistance,” “antimicrobial susceptibility testing,” “antibiotic susceptibility testing,” and “Ethiopia.” These terms were applied to the titles and abstracts of relevant publications. The search strategy was developed by using the above MeSH terms with a combination of Boolean operators: “AND,” “NOT,” and “OR”. ((neonate) OR (newborn)) AND (sepsis)) OR (bacterial sepsis)) OR (Gram-positive bacteria)) OR (Gram-negative bacteria)) OR (neonatal sepsis)) OR bacterial profile OR (antimicrobial susceptibility testing)) OR (antimicrobial resistance)) OR (antibiotic susceptibility pattern)) AND (associated factors)) OR (risk factors)) AND (Ethiopia) by all fields in PubMed. The quality of the primary studies was evaluated for each article included in the study.

Selection criteria

In this systematic review and meta-analysis, studies were excluded if they provided aggregated data that did not clearly identify region-specific information or distinguish neonates from older children or adults. Additionally, studies were excluded for lacking sufficient information on the types of Gram-negative and Gram-positive bacteria or antimicrobial susceptibility, or for reporting infections from non-sterile sites. To ensure relevance to the current epidemiology of neonatal sepsis in Ethiopia, we decided to exclude studies published before 2015 and those where the majority of isolates were from prior to that year. The authors selected only studies that conducted disk diffusion methods and studies that had the same operationalized definition of the MDR. Case reports or studies involving fewer than 50 neonates were also excluded due to potential bias in participant selection. Abstracts and titles were compiled in EndNote version 21, and duplicates were removed. Three investigators (HB, AT, and BAT) independently reviewed the identified articles for eligibility, retrieving the full text of all eligible studies. For articles where the full text could not be accessed or where results required clarification, we contacted the corresponding authors directly via email. Non-English articles were excluded. Any disagreements regarding inclusion were resolved by consensus between the three investigators.

Data extraction

The authors created a data extraction form in an Excel spreadsheet to collect relevant information from eligible studies. The following data points were extracted: prevalence reported by the first author, instances of bacterial neonatal sepsis, year of publication, region, study setting, design, sample size, total bacterial isolates, prevalence of Gram-positive and Gram-negative bacteria, commonly isolated species Staphylococcus aureus (S. aureus), coagulase-negative Staphylococcus (CoNS), Enterococcus spp, Streptococcus spp, Group B streptococcus (GBS), Escherichia coli (E. coli), Klebsiella pneumoniae (K. pneumoniae), Enterobacter spp, Citrobacter spp, Acinetobacter spp, Pseudomonas spp and Serratia spp, antimicrobial resistance patterns for each isolate, prevalence of multidrug resistance, and odds ratios for risk factors (AOR). The data extraction sheet was piloted with four randomly selected papers and adjusted accordingly. Two authors (HB and AT) collaboratively extracted the data, while the third author (GAA) independently verified the accuracy of the data. Any disagreements among reviewers were resolved through discussions, involving the third reviewer as needed. Mistyped data were corrected by cross-referencing with the original papers.

Quality assessment

The authors assessed the quality of the studies using the Joanna Briggs Institute (JBI) quality appraisal checklist.²³ HB and AT independently assessed the quality of the papers, with any disagreements resolved through discussion with the third and fourth reviewers, AA and BAT. Studies scoring 4 or higher across all designs (cross-sectional, retrospective, and cohort) were considered high or of good quality,²³ studies scoring 3 or lower were classified as low or poor quality (Supplemental File 2).

Statistical analysis, study heterogeneity, and publication

The authors transferred the extracted data from Excel to STATA 17 for analysis. Using a random-effects meta-analysis model to account for heterogeneity, we pooled the overall prevalence estimates of bacterial neonatal sepsis, MDR among isolated bacteria in individual studies, and adjusted odds ratios (AOR) for associated factors. Antimicrobial resistance was calculated for the commonly isolated Gram-positive and Gram-negative bacteria for the commonly used antimicrobials. We assessed the heterogeneity of effect sizes using the Q statistic and I² statistic. In this study, an I² value of zero indicated true homogeneity, while values of 25%, 50%, and 75% represented low, moderate, and high heterogeneity, respectively.^24,25 Subgroup analysis was conducted based on study region, study design, and year of publication to evaluate variations in pooled estimates across different categories and to assess the heterogeneity between studies. Galbraith plot was used to summarize the heterogeneity. Publication bias was investigated using a funnel plot and further analyzed more objectively through Egger’s regression test.^26,27

Results

Our search produced a total of 9013 results, 8617 studies from electronic databases and 198 from other search strategies. Of these, 309 studies were deemed eligible for full-text screening. After reviewing the full texts, 289 studies were excluded for various reasons, leaving 20 studies that met the eligibility criteria and were included in the final systematic review and meta-analysis (Figure 1).

Figure 1.

PRISMA flow chart and selection process for the systematic review and meta-analysis of bacterial neonatal sepsis, antimicrobial resistance, and risk factors among neonates in Ethiopia, 2025.

Characteristics of the included original studies

The 20 original studies were published between 2015 and 2025. There were seven studies from the Amhara region, University of Gondar comprehensive specialized hospital,^9,18,28,29 Bahir Dar, Felege-Hiwot referral Hospital,³⁰ Dessie town public health facilities and comprehensive specialized hospital,^31,32 one study from Amhara, Gondar University Hospital³³ and Addis Ababa, Tikur Anbessa Specialized Hospital, St. Paul’s Millennium Medical College and Ghandi Memorial Hospital³³ and Oromia, Jimma University Medical Centre.³³ Debub, Ethiopia region, Arba Minch Hospital,¹¹ Tigray region, Ayder Comprehensive Specialized Hospital,³⁴ Oromia region three studies, Arsi University Teaching and Referral Hospital,³⁵ Jimma medical centre,³⁶ Somalia region, Health Facilities in Jigjiga City,³⁷ Addis Ababa,^38–41 multicentre cluster study with three tertiary hospitals, namely central (Tikur Anbessa Specialized Hospital), western (Jimma University medical centre), and southern (Hawassa University Comprehensive Specialized Hospital), Ethiopia,⁴² Sidama region, Hawassa University Comprehensive Specialized Hospital.⁴³ Most studies (n = 17) used a cross-sectional design. All studies were reported in the hospital and health facilities (Supplemental File study characteristics).

Bacteriological identification and antimicrobial susceptibility testing were reported from all included studies (100%), respectively. All antimicrobial susceptibility testing methods were performed using the disk diffusion method. The final studies included in this review had a combined sample size of 11,754, yielding a total of 3168 bacterial isolates. Of these, 837 were Gram-positive bacteria and 2328 were Gram-negative. The most commonly identified bacterial isolates in this review were K. pneumoniae (1343), E. coli (854), S. aureus (356), other Klebsiella spp (K. oxytocia, K. ozanae, K. rhinoscleromatis, and K. rhinose) (234), CoNS (192), Acinetobacter species (172), GBS (164), Enterobacter spp (85), Citrobacter spp (63), Enterococcus spp (49), Streptococcus spp (36), and Pseudomonas spp (31). The total MDR bacterial isolates in this systematic review were 2306. The blood culture positivity prevalence across the 20 studies was ranged from 5.5%¹¹ to 48.7%.²⁹ The characteristics of all the 20 included studies were presented in the Supplemental File 3.

Meta-analysis

Prevalence of bacterial neonatal sepsis in Ethiopia

The estimated pooled prevalence of bacterial neonatal sepsis caused by bacterial organisms in Ethiopia from this meta-analysis was 29.92% (25.79% to 34.05%, I² = 84.12%, p < 0.000). This review found significant heterogeneity among the studies and performed by using a random effect model (Figure 2).

Figure 2.

Pooled prevalence of bacterial neonatal sepsis in Ethiopia, 2025.

Subgroup meta-analysis was performed to investigate the source of heterogeneity based on region, publication year, and study design. According to this subgroup analysis, the prevalence of bacterial neonatal sepsis in the Amhara region was 31.56 (24.72% to 38.39%, I² = 85.17, p < 0.0001; Table 1).

Table 1.

The pooled antimicrobial resistance of Gram-positive bacteria among bacterial neonatal sepsis suspected neonates in Ethiopia, 2015–2025.

Gram-positive Bacteria (n)	Antimicrobial resistance pattern
Gram-positive Bacteria (n)	P n (%)	FOX n (%)	ERY n (%)	CLN	CN	SXT	TE	CRO	OX	CIP	CHL	AMP	VAC
S. aureus (334)	157 (47)	91 (27)	156 (46.7)	71 (14)	102 (30.5)	115 (34.4)	70 (21)	96 (28.7)	92 (27.5)	81 (24.3)	49 (14.7)	74 (22)	7 (2)
CoNS (196)	142 (72.4)	95 (48.5)	81 (41.3)	50 (21.1)	120 (61.2)	84 (42.9)	70 (35.7)	66 (33.7)	78 (39.8)	48 (24.5)	19 (9.7)	41 (20.9)	11 (5.6)
GBS (153)	30 (19.6)	2 (1.3)	20 (13.1)	19 (8.5)	–	–	64 (41.8)	25 (16.3)	2 (1.3)	21 (13.7)	5 (3.3)	18 (11.8)	12 (7.8)
Enterococcus spp (17)	11 (64.7)	3 (17.6)	3 (17.6)	5 (29.4)	5 (29.4)	4(23.6)	3 (17.7)	3(17.6)	5(29.4)	–	5(29.4)	1(5.9)	4(23.5)
S. viridians (34)	2 (5.9)	2 (5.9)	1 (2.9)	3 (8.8)	1 (2.9)	1(2.9)	2 (5.9)	2 (5.9)	2 (5.9)	1 (2.9)	–	13 (38.2)	3 (8.8)
Streptococcus spp (26)	5 (19.2)	1 (3.8)	5 (19.2)	1 (3.8)	4 (15.4)	7(26.9)	3 (11.5)	2 (7.7)	1 (3.8)	3 (11.5)	1 (3.8)	1 (3.8)	1 (3.8)
Unknown bacteria (5)	2 (40)	1 (20)	2 (40)	2 (40)	–	1(20)	1 (20)	1 (20)	1 (20)	–	–	–	–

AMP, ampicillin; CHL, Chloramphenicol; CIP, ciprofloxacin; CLN, Clindamycin; CN, gentamicin; CRO, ceftriaxone; ERY, Erythromycin; FOX, Cefoxitine; OX, oxacillin; P, Penicillin; SXT, sulfamethoxazole-trimethoprim; TE, tetracycline; VAN: Vancomycin; –, not applicable.

Variables	Characteristics	No of studies	Prevalence (95%CI)	I ²
Region	Amhara	7	31.56% (24.72 to 38.39%)	85.17%
	Oromia	4	31.62% (22.83% to 41.41%)	86.8%
	Addis Ababa	4	21.75% (17.31 % to 26.20%)	12.37%
	Sidama	2	35.77% (29.68% to 41.86%)	0.00%
	Somalia	1	41.70% (29.89 to 53.51%)	–
	Tigray	1	36.6% (27.87 to 45.33%)	–
	Debub Ethiopia	1	5.5% (−7.97% to 18.97%)	–
Publication Year	>2020	13	27.60% (22.96% to 32.24%)	83.04%
	⩽2020	7	34.54% (27.55% to 41.54%)	76.86%
Study Design	Cross-sectional	17	30.92% (26.19 to 35.65%)	83.23%
	Others	3	25.05% (18.79 to 32.24%)	72.43%

Others; retrospective and cohort.

Significant heterogeneity was detected in all meta-analyses and subgroup analyses. Due to limitations of data in all regions of the country and a small number of data in Somalia, Tigray, and Debub Ethiopia, we were unable to identify clear sources of this heterogeneity.

Findings from Egger’s meta-regression test showing below evaluating the presence of small-study effects in the 20 studies examining bacterial neonatal sepsis caused by both Gram-positive and Gram-negative bacteria.

Parameter	Estimate	Standard error	t Value	p-Value	95% CI
Slope (coefficient)	0.0390	0. 103	0.38	0.709	0.178–0.256
Bias (intercept)	2.298	3.086	0.74	0.467	4.213–8.810

Test of residual homogeneity: small-study effects, p value = 0.467.

We acknowledge that the extent of prevalence variation directly indicates publication bias. To examine the prevalence and the statistical significance of small-study effects, we performed Egger’s meta-regression analysis. The test yielded a p-value greater than 0.05 and a 95% confidence interval that does not include 1, indicating no evidence of publication bias, and also the funnel plot in this meta-analysis indicated that there was no small study effect in the sensitivity analysis performed (Figure 3).

Figure 3.

The funnel plot of the 20 included studies in bacterial neonatal sepsis in Ethiopia.

The pooled prevalence of Gram-positive and Gram-negative bacteria were 31.02% (95% CI: 22.64% to 39.41%) and 50.77% (95% CI: 39.39% to 62.16%), respectively. The pooled prevalence of the predominantly isolated Gram-positive bacteria in the neonate in this review was: S. aureus 51.80% (95% CI: 40.62% to 62.99%), CoNS 41.29% (95% CI: 25.89% to 56.69%), and GBS 60.60% (95% CI: 24.18% to 97.02%). From Gram-negative bacteria, K. pneumoniae 45.03% (95% CI: 35.83% to 54.22%), E. coli 27.56% (95% CI: 13.83% to 41.29%), Acinetobacter spp 11.00% (95% CI: 6.39% to 15.60%), Enterobacter spp 7.20% (95% CI: 1.95% to 12.45%), and Citrobacter spp 4.30% (−0.69 to 9.29%) were the common isolates in this review (S1 Data).

Antimicrobial resistance

The antimicrobial selections in all primary studies of this meta-analysis varied according to CLSI guidelines. Based on the original studies, the pooled prevalence of penicillin resistance was 47% for S. aureus, 72.5% for CoNS, 64.7% for Enterococcus spp, and 19.7% for GBS. The substantial resistance of all antimicrobials was shown for all Gram-positive bacteria (Table 1).

The most isolated Gram-negative bacteria were resistant to the most commonly used antimicrobials in the country. In this review, we observed that the pooled substantial resistance of gentamicin from 27.1% to 87.5% in each specified Gram-negative bacteria. High level of resistance to ceftriaxone was noted in Klebsiella spp, E. coli, Enterobacter spp, Salmonella spp, and P. aeruginosa (62.7%–87.5%; Table 2).

Table 2.

The pooled antimicrobial resistance of Gram-negative bacteria among bacterial neonatal sepsis suspected neonates in Ethiopia, 2015–2025.

Gram-negative bacteria (n)	Antimicrobial resistance pattern
Gram-negative bacteria (n)	CN n (%)	AMP n (%)	CAZ n (%)	AUG n (%)	CHL n (%)	TE n (%)	CRO n (%)	SXT n (%)	CIP n (%)	CFO n (%)	NR n (%)	AK n (%)	MRO n (%	)PTZ n (%)	TOB n (%)	PEF n (%)	CPN n (%)	ETP n (%)	IMP n (%)
Klebsiella spp (775)	514 (66.3	345 (44.5	)507 (65.4)	353 (45.5)	276 (35.6)	133 (17.2)	563 (72.6)	585 (75.5)	351 (45.3)	140 (18.1)	16 (2.1)	116 (15)	87 (11.2)	104 (13.4)	173 (22.3)	91 (11.7)	80 (10.3)	11 (1.4)	60 (7.7)
E.coli (251)	68 (27.1)	122 (80.3)	68 (27.1)	76 (30.3)	38 (15.1)	27 (10.8)	77 (30.7)	100 (81.3)	39 (15.3)	9 (3.6)	6 (2.4)	15 (6)	13 (5.2)	27 (10.8)	19 (7.6)	8 (3.2)	15 (6)	2 (0.8)	7 (0.9)
Serrasia spp (19)	13 (68.4)	16 (84.2)	14 (73.7)	15 (78.9)	5 (26.3)	8 (42)	13 (6.8)	12 (63.2)	5 (26.3)	1 (5.3)	4 (21.1)	1 (5.3)	1 (5.2)	NT	NT	NT	NT	NT	NT
Enterobacter spp (75)	45 (60)	54 (72)	40 (53.3)	39 (52)	30 (40)	14 (18.7)	47 (62.7)	45 (60)	35 (46.7)	4 (5.3)	1 (1.3)	9 (12)	6 (6)	9 (12)	14 (18.7)	6 (8)	1 (1.3)	NT	10 (13.3)
Acinetobacter spp (123)	64 (52)	41 (33.3)	82 (66.7)	31 (25.2)	23 (18.7)	9 (7.3)	52 (42.3)	46 (37.4)	42 (34)	19 (25.3)	NT	19 (15.4)	26 (21.1)	24 (19.5)	27 (22)	6 (4.9)	24 (19.5)		NT
Salmonella spp (8)	7 (87.5)	7 (87.5)	7 (87.5)	7 (87.5)	3 (37.5)	1 (12.5)	7 (87.5)	6 (75)	3 (37.5)	3 (37.5)	NT	NT	2 (25)	1 (12.5)	3 (37.5)	NT	NT	NT	NT
P. aeruginosa (53)	26 (49.1)	28 (52.8)	17 (32.1)	12 (22.6)	13 (24.5)	4 (7.5)	35 (66)	28 (52.8)	30 (56.6)	4 (7.5)	4 (7.5)	1 (1.9)	1 (1.9)	7 (13.2)	7 (13.2)	NT	5 (9.4)	NT	NT
Citrobacter spp (64)	40 (62.5)	56 (87.5)	13 (20.3)	16 (25)	25 (39)	22 (34.4)	35 (54.7)	33 (51.6)	11 (17.2)	10 (15.6)	3 (4.7)	3 (4.7)	2 (3.1)	1 (1.6)	2 (3.1)	NT	1 (1.6)	NT	1 (1.6)
Proteus spp (7)	4 (57.1)	5 (71.4)	1 (14.3)	1 (14.3)	2 (28.6)	NT	2 (28.6)	2 (28.6)	5 (71.4)	NT	NT	2 (28.6)	2 (28.6)	NT	NT	NT	NT	NT	NT
Unknown bacteria (10)	6 (60)	8 (80)	5 (50)	6 (60)	6 (60)	6 (60)	5 (50)	6 (60)	3 (30)	NT	NT	NT	NT	NT	NT	NT	NT	NT	NT

AK, amikacin; AMP, ampicillin; AUG, amoxicillin clavulanic acid; CAZ, ceftazidime; CFO, cefotaxime; CHL, chloramphenicol; CIP, ciprofloxacin; CN, gentamicin; CRO, ceftriaxone; ETP, ertapenem; IPM, imipenem; MRO, meropenem; NR, norfloxacin; PEF, pefloxacin; PTZ, piperacillin; SXT, sulfamethoxazole-trimethoprim; TE, tetracycline; TOB, Tobramycin.

Multidrug resistance

This systematic review and meta-analysis identifies 2,306 MDR bacterial isolates with a different prevalence of each region in Ethiopia; the highest prevalence of MDR bacteria was identified among included studies conducted by Gadisa et al. (95.7%).⁴² The prevalence of MDR bacterial suspected neonates in Amhara ranges from 24.2% to 78.2%.^{9,18,28,29,31,32} Tigray (88%), Oromia 88.4% and 95.7%,^36,42 Addis Ababa (42% to 92%).^33,38–41 The overall pooled prevalence of MDR in Ethiopia among bacterial neonatal sepsis was 66.20%(55.43 to 76.97%,) with higher heterogeneity (I² = 98.09) and statistically significant at (p < 0.0001; Figure 4).

Figure 4.

The pooled prevalence of multidrug resistance from bacterial isolates among neonates in Ethiopia, 2015–2025.

To assess the heterogeneity among studies reporting MDR, a Galbraith plot is employed to visually examine the variation in effect sizes across the studies. This plot displays the standardized effect sizes against their precision, allowing identification of studies that deviate substantially from the overall trend. By plotting these values, the Galbraith plot helps detect outlier MDR results that may contribute disproportionately to heterogeneity (Figure 5), and the subgroup meta-analysis of MDR by region was presented (D2 data).

Figure 5.

The Galbraith plot shows the heterogeneity of MDR between studies.

Associated risk factors for bacterial neonatal sepsis in Ethiopia

There are a number of associated factors that increase the burden of bacterial neonatal sepsis in different pocket studies, but from the 20 included studies had different variables, such as intrapartum antibiotic prophylaxis,³⁵ vaginal discharge,¹¹ long hospitalization of the infant,^34,38,42 increased respiration infections (suspicion pneumonia, lower respiratory tract infection and meningitis),^9,39 gestational age < than 37 weeks at birth,^28,29,42 multidrug-resistant status,³⁸ resuscitation required, parity (nulipara), gravidity and low Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score¹⁸ were associated. However, from this systematic review and meta-analysis, we selected variables that had at least four and more studies associated in common from the primary studies. From this meta-analysis, we found that the four risk factors of preterm birth, PROM, history of UTI at ANC, and LBW were found in common and significantly associated with bacterial neonatal sepsis in Ethiopian neonates (Figure 6(a)–(d)).

Figure 6.

(a, b, c, d) Illustrating associations of risk factors with neonatal sepsis in Ethiopia.

Discussion

Bacterial neonatal sepsis continues to be a significant cause of morbidity and mortality among newborns worldwide, with developing nations such as Ethiopia facing a disproportionately high burden. This systematic review and meta-analysis consolidates data from multiple studies to offer a thorough estimate of the prevalence of neonatal sepsis in Ethiopia, revealing a pooled prevalence of 29.92%. The strength of this meta-analytic approach lies in its ability to combine findings from various regional studies, thereby accounting for differences in study designs and population characteristics, which enhances the accuracy of the estimate. Notably, the prevalence of neonatal sepsis in low- and middle-income countries, particularly in regions of Africa (15.5%) and Asia (28%), and the overall pooled prevalence is generally lower (19.1%)⁴⁴ and Ethiopia (23%).⁹ This indicated that the current meta-analysis underscores an urgent need for targeted interventions, early diagnosis, infection prevention, and appropriate antibiotic use in the study regions in Ethiopia.

The pooled prevalence of Gram-positive and Gram-negative bacteria in neonatal sepsis in this review was 31.02% and 50.77%, respectively. The prevalence of Gram-negative bacteria closely aligns with findings from studies in low- and lower-middle-income countries (60%),⁴⁵ Iran (53.6%),⁴⁶ and (63.9%),⁴⁴ Ethiopia (75.3%)⁹ and Gram-positive bacteria (35.8%)⁴⁴ an (24.7%).⁹ In the current review, the most commonly identified bacterial isolates in neonatal sepsis in Ethiopia were S. aureus (51.8%), GBS (60.60%), K. pneumoniae (45.03%), E. coli (27.56%), Acinetobacter spp (11.0%), Enterobacter spp (7.2%), and Citrobacter spp (4.3%). This meta-analysis reveals a consistent finding with other studies conducted,^{44,45,47–50} Ethiopia K. pneumoniae (38.7%) and S. aureus (13%).⁹ A systematic review and meta-analysis in developing countries reported a high a pooled prevalence of S. aureus, Klebsiella spp, and E. coli accounted for (39%–70%) of culture-positive neonatal sepsis.⁴⁷

The overall pooled prevalence of MDR in this meta-analysis from bacterial neonatal sepsis was 66.20%, with the regional subgroup meta-analysis of MDR in Oromia (92.43%), Addis Ababa (70.49%), Tigray (88%), and Amhara (59.99%). These figures are at the upper range or exceed many reported MDR rates, reflecting significant challenges in antimicrobial resistance, similarly low- and middle-income countries (LMICs) studies across Africa and Asia often report high MDR prevalence (50% and 80%)^51,52 due to factors like limited antibiotic stewardship and resource constraints. The high regional variation within Ethiopia also mirrors disparities seen in LMICs, driven by differences in healthcare infrastructure, local antimicrobial usage, and infection control practices. AMR is pervasive in every region in Ethiopia, including third-generation cephalosporin, penicillin groups and aminoglycosides, our review data must be considered within the boarder context of widespread in Ethiopia⁵³ due this the Gram-positive bacteria is the most common cause of neonatal sepsis and resistant to the mostly prescribed antimicrobials, S. aureus was resistant to penicillin (47%), erythromycin (46.7%), sulfamethoxazole-trimethoprim (34.4%), gentamicin (30%), ceftriaxone (28.7%). CoNS was resistant to penicillin (72%), gentamicin (61%), cefoxitin (48.5%), and sulfamethoxazole-trimethoprim (42%). Gram-negative bacteria, Klebsiella spp was resistant to gentamicin (66.3%), ceftazidime (65.4%), and sulfamethoxazole-trimethoprim (75%). In this review, we observed that AMR in each region was different, and region-specific antimicrobial stewardship to prescribe antimicrobials is a mandatory issue in Ethiopia among neonates. A dynamic review of current recommendations and their relevance can be enabled by this approach. At the same time, it is essential to prioritize the development of new antimicrobial strategies specifically targeting MDR bacterial pathogens suitable for the Ethiopian context. Moreover, the optimal dosing and treatment duration for both repurposed and novel antimicrobials effective against MDR bacterial infections often remain unclear, particularly for neonates.⁵⁴

The result of this meta-analysis showed that maternal, neonatal, and environmental factors had a significant effect on the risk of neonatal sepsis. From the many risk factors observed, we identified four factors significantly associated with neonatal bacterial sepsis.

We found that preterm birth was associated with 8.2 times higher odds of exposure to bacterial neonatal sepsis compared to term births. This finding is consistent with a substantial body of evidence from studies conducted across diverse geographical settings.^55–57 The consistency of this finding across varied populations, healthcare systems, and geographic regions suggests that the relationship between prematurity and neonatal sepsis is not context-dependent but rather reflects underlying physiological vulnerabilities common to preterm infants, including immature immune function, reduced trans placental antibody transfer, increased need for invasive procedures, and prolonged hospitalization.⁵⁸

We found that PROM was associated with 4.8 times higher odds of bacterial neonatal sepsis. This finding aligns with evidence from multiple studies across different settings, reflecting the increased risk of ascending infection following membrane rupture.^59–61 Prolonged exposure to the vaginal environment after membrane rupture facilitates microbial invasion, leading to early-onset neonatal sepsis

Maternal urinary tract infection during antenatal care is a recognized risk factor for neonatal infections. In this study, the history of UTI at ANC was associated with 33.21 times higher exposure to bacterial neonatal sepsis. Similar findings have been reported from other studies,^62,63 supporting the role of maternal UTI as a significant contributor to neonatal infectious risk, likely through ascending infection, intrapartum transmission, or shared urogenital pathogens.

In this systematic review and meta-analysis, LBW was found to significantly increase the risk of bacterial neonatal sepsis by 13.73 times. This finding is consistent with previous studies,^64,65 underscoring the vulnerability of LBW infants due to immunological immaturity, prolonged hospitalization, and increased exposure to invasive procedures.

This systematic review and meta-analysis have some limitations. The geographic location of the included studies makes our findings not necessarily generalizable. The Amhara region (35%), Oromia, and Addis Ababa (20%) were included in the study, and some regions were not represented in this review. The systematic review and meta-analysis have several limitations; in this review, we included different study designs, which limits the generalizability, English language restriction is also a possible risk of bias and is a limitation. We could not have performed the heterogeneity of identified risk factors and antimicrobial resistance. The variability in study sample sizes might affect the stability of the pooled estimates. This systematic review was only selected studies that have performed only disk diffusion techniques for antimicrobial susceptibility testing and will recommend future research on molecular methods and (ESBL, carbapenems).

Conclusion

Bacterial neonatal sepsis in our current meta-analysis in Ethiopia is relatively high due to increased bacterial infections by both Gram-positive and Gram-negative bacteria. AMR in this systematic and meta-analysis showed that becoming alarming and the most prescribed antimicrobials (penicillin, cephalosporin, and aminoglycoside) were resistant in different identified bacteria in regions of Ethiopia, and higher MDR was observed. The associated key risk factors identified in this meta-analysis were premature rupture of membranes, maternal urinary tract infections during antenatal care, low birth weight (<2.5 kg), and preterm birth. To prevent bacterial neonatal sepsis, early diagnosis and treatment are essential. Periodic AMR surveillance, stewardship, infection control, and reporting are essential to guide region-specific antimicrobial use. Highlighting the need for routine screening, enhancing antenatal care, training healthcare providers in early sepsis diagnosis and management, and enforcing strict infection control practices are critical concerns to reduce bacterial neonatal sepsis in neonates. Low- to moderate-certainty evidence suggests that prior antibiotic exposure is a key risk factor for antimicrobial-resistant bacterial neonatal sepsis. Evidence for neonatal sepsis in this review was low, and other outcomes identified risk factors that remain of high certainty due to confounding, imprecision, and inconsistent resistance definitions. Findings warrant cautious interpretation and highlight the need for standardized, high-quality prospective studies.

Supplemental Material

sj-docx-1-tai-10.1177_20499361261451360 – Supplemental material for Bacterial neonatal sepsis, antimicrobial resistance, and risk factors among neonates in Ethiopia: a systematic review and meta-analysis

Supplemental material, sj-docx-1-tai-10.1177_20499361261451360 for Bacterial neonatal sepsis, antimicrobial resistance, and risk factors among neonates in Ethiopia: a systematic review and meta-analysis by Habtamu Belew, Bantayehu Addis Tegegne, Yonatan Kindie, Adane Tilahun, Mastewal Yechale Mihret, Zigale Hibstu Teffera, Adane Adugna, Gashaw Azanaw Amare, Desalegn Abebaw, Mekuriaw Belayneh and Mamaru Getinet in Therapeutic Advances in Infectious Disease

Supplemental Material

sj-docx-2-tai-10.1177_20499361261451360 – Supplemental material for Bacterial neonatal sepsis, antimicrobial resistance, and risk factors among neonates in Ethiopia: a systematic review and meta-analysis

Supplemental material, sj-docx-2-tai-10.1177_20499361261451360 for Bacterial neonatal sepsis, antimicrobial resistance, and risk factors among neonates in Ethiopia: a systematic review and meta-analysis by Habtamu Belew, Bantayehu Addis Tegegne, Yonatan Kindie, Adane Tilahun, Mastewal Yechale Mihret, Zigale Hibstu Teffera, Adane Adugna, Gashaw Azanaw Amare, Desalegn Abebaw, Mekuriaw Belayneh and Mamaru Getinet in Therapeutic Advances in Infectious Disease

Supplemental Material

sj-docx-3-tai-10.1177_20499361261451360 – Supplemental material for Bacterial neonatal sepsis, antimicrobial resistance, and risk factors among neonates in Ethiopia: a systematic review and meta-analysis

Supplemental material, sj-docx-3-tai-10.1177_20499361261451360 for Bacterial neonatal sepsis, antimicrobial resistance, and risk factors among neonates in Ethiopia: a systematic review and meta-analysis by Habtamu Belew, Bantayehu Addis Tegegne, Yonatan Kindie, Adane Tilahun, Mastewal Yechale Mihret, Zigale Hibstu Teffera, Adane Adugna, Gashaw Azanaw Amare, Desalegn Abebaw, Mekuriaw Belayneh and Mamaru Getinet in Therapeutic Advances in Infectious Disease

Footnotes

Acknowledgements

We thank the authors of the original studies included in this review for their contributions, which made this evidence possible.

Declarations

ORCID iDs

Habtamu Belew

Bantayehu Addis Tegegne

Yonatan Kindie

Mastewal Yechale Mihret

Adane Adugna

Gashaw Azanaw Amare

Desalegn Abebaw

Supplemental material

Supplemental material for this article is available online.

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