Summary of findings 1. Ampicillin plus gentamicin compared with penicillin plus gentamicin for early‐onset neonatal sepsis.
| Ampicillin + gentamicin compared with penicillin + gentamicin for early‐onset neonatal sepsis | ||||||
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Patient or population: neonates with early‐onset sepsis Settings: neonatal intensive care unit in Estonia Intervention: ampicillin + gentamicin Comparison: penicillin + gentamicin | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Penicillin + gentamicin | Ampicillin + gentamicin | |||||
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All‐cause mortality maximum follow‐up |
163 per 1000 | 91 per 1000 (49 to 173) |
RR 0.56 (0.30 to 1.06) |
283 (1) | ⊕⊝⊝⊝ Very lowa | OIS: 3898 (RR 0.80, α 0.05, β 0.20) |
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Serious adverse events maximum follow‐up |
461 per 1000 | 428 per 1000 (332 to 558) |
RR 0.93 (0.72 to 1.21) |
283 (1) | ⊕⊝⊝⊝ Very lowa | OIS: 992 (RR 0.80, α 0.05, β 0.20) The serious adverse events were need for vasoactive drugs. |
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Circulatory support maximum follow‐up |
461 per 1000 | 428 per 1000 (332 to 558) |
RR 0.93 (0.72 to 1.21) |
283 (1) | ⊕⊝⊝⊝ Very lowa | OIS: 992 (RR 0.80, α 0.05, β 0,20) |
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Neurological developmental impairment maximum follow‐up |
113 per 1000 | 92 per 1000 (45 to 183) |
RR 0.81 (0.40 to 1.61) |
283 (1) | ⊕⊝⊝⊝ Very lowa | OIS: 5592 (RR 0.80, α 0.05, β 0.20) Participants with intraventricular haemorrhage type III to IV. |
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Necrotising enterocolitis maximum follow‐up |
57 per 1000 | 70 per 1000 (28 to 173) |
RR 1.24 (0.50 to 3.05) |
283 (1) | ⊕⊝⊝⊝ Very lowa | OIS: 11822 (RR 0.80, α 0.05, β 0.20) |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; OIS: optimal information size; RR: risk ratio. | ||||||
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GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
aDowngraded three levels because of very serious risk of bias, very serious imprecision of results, and serious risk of indirectness.