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. 2021 May 17;5(5):CD013837.
doi: 10.1002/14651858.CD013837.pub2.

Antibiotic regimens for early-onset neonatal sepsis

Steven Kwasi Korang  1 , Sanam Safi  1 , Chiara Nava  2 , Adrienne Gordon  3 , Munish Gupta  4 , Gorm Greisen  5 , Ulrik Lausten-Thomsen  6 , Janus C Jakobsen  1   7
Affiliations

Antibiotic regimens for early-onset neonatal sepsis

Steven Kwasi Korang et al. Cochrane Database Syst Rev. .

Abstract

Background: Neonatal sepsis is a major cause of morbidity and mortality. It is the third leading cause of neonatal mortality globally constituting 13% of overall neonatal mortality. Despite the high burden of neonatal sepsis, high-quality evidence in diagnosis and treatment is scarce. Possibly due to the diagnostic challenges of sepsis and the relative immunosuppression of the newborn, many neonates receive antibiotics for suspected sepsis. Antibiotics have become the most used therapeutics in neonatal intensive care units. The last Cochrane Review was updated in 2004. Given the clinical importance, an updated systematic review assessing the effects of different antibiotic regimens for early-onset neonatal sepsis is needed.

Objectives: To assess the beneficial and harmful effects of different antibiotic regimens for early-onset neonatal sepsis.

Search methods: We searched the following electronic databases: CENTRAL (2020, Issue 8); Ovid MEDLINE; Embase Ovid; CINAHL; LILACS; Science Citation Index EXPANDED and Conference Proceedings Citation Index - Science on 12 March 2021. We searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-RCTs.

Selection criteria: We included RCTs comparing different antibiotic regimens for early-onset neonatal sepsis. We included participants from birth to 72 hours of life at randomisation.

Data collection and analysis: Three review authors independently assessed studies for inclusion, extracted data, and assessed risk of bias. We used the GRADE approach to assess the certainty of evidence. Our primary outcome was all-cause mortality, and our secondary outcomes were: serious adverse events, respiratory support, circulatory support, nephrotoxicity, neurological developmental impairment, necrotising enterocolitis, and ototoxicity. Our primary time point of interest was at maximum follow-up.

Main results: We included five RCTs (865 participants). All trials were at high risk of bias. The certainty of the evidence according to GRADE was very low. The included trials assessed five different comparisons of antibiotics. We did not conduct any meta-analyses due to lack of relevant data. Of the five included trials one trial compared ampicillin plus gentamicin with benzylpenicillin plus gentamicin; one trial compared piperacillin plus tazobactam with amikacin; one trial compared ticarcillin plus clavulanic acid with piperacillin plus gentamicin; one trial compared piperacillin with ampicillin plus amikacin; and one trial compared ceftazidime with benzylpenicillin plus gentamicin. None of the five comparisons found any evidence of a difference when assessing all-cause mortality, serious adverse events, circulatory support, nephrotoxicity, neurological developmental impairment, or necrotising enterocolitis; however, none of the trials were near an information size that could contribute significantly to the evidence of the comparative benefits and risks of any particular antibiotic regimen. None of the trials assessed respiratory support or ototoxicity. The benefits and harms of different antibiotic regimens remain unclear due to the lack of well-powered trials and the high risk of systematic errors.

Authors' conclusions: Current evidence is insufficient to support any antibiotic regimen being superior to another. Large RCTs assessing different antibiotic regimens in early-onset neonatal sepsis with low risk of bias are warranted.

PubMed Disclaimer

Conflict of interest statement

The project received no funding.

SKK: none.

SS: none.

CN: none.

MG: none.

AG: none.

GG: none.

ULT: none.

JCJ: none.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Ampicillin plus gentamicin compared with benzylpenicillin plus gentamicin, Outcome 1: All‐cause mortality
1.2
1.2. Analysis
Comparison 1: Ampicillin plus gentamicin compared with benzylpenicillin plus gentamicin, Outcome 2: Serious adverse events
1.3
1.3. Analysis
Comparison 1: Ampicillin plus gentamicin compared with benzylpenicillin plus gentamicin, Outcome 3: Circulatory support
1.4
1.4. Analysis
Comparison 1: Ampicillin plus gentamicin compared with benzylpenicillin plus gentamicin, Outcome 4: Neurological developmental impairment
1.5
1.5. Analysis
Comparison 1: Ampicillin plus gentamicin compared with benzylpenicillin plus gentamicin, Outcome 5: Necrotising enterocolitis
2.1
2.1. Analysis
Comparison 2: Piperacillin plus tazobactum compared with amikacin, Outcome 1: All‐cause mortality
2.2
2.2. Analysis
Comparison 2: Piperacillin plus tazobactum compared with amikacin, Outcome 2: Serious adverse events
3.1
3.1. Analysis
Comparison 3: Ticarcillin plus clavulanic acid compared with piperacillin plus gentamicin, Outcome 1: All‐cause mortality
3.2
3.2. Analysis
Comparison 3: Ticarcillin plus clavulanic acid compared with piperacillin plus gentamicin, Outcome 2: Serious adverse events
4.1
4.1. Analysis
Comparison 4: Piperacillin compared with ampicillin plus amikacin, Outcome 1: All‐cause mortality
4.2
4.2. Analysis
Comparison 4: Piperacillin compared with ampicillin plus amikacin, Outcome 2: Serious adverse events
4.3
4.3. Analysis
Comparison 4: Piperacillin compared with ampicillin plus amikacin, Outcome 3: Nephrotoxicity
5.1
5.1. Analysis
Comparison 5: Ceftazidime compared with benzylpenicillin plus gentamicin, Outcome 1: All‐cause mortality
5.2
5.2. Analysis
Comparison 5: Ceftazidime compared with benzylpenicillin plus gentamicin, Outcome 2: Serious adverse events
See this image and copyright information in PMC

Update of

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