Hammerberg 1989.
Study characteristics | ||
Methods | Randomised controlled trial Duration: at the discretion of the attending neonatologist. Maximum duration 10 days Date: NA Location: NICU in Canada |
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Participants | 396 infants suspected of early‐onset sepsis Inclusion criteria: had combination of risk factors or clinical signs (or both) compatible with sepsis; aged < 7 days of life Gender (boy/girl): NA Age: median gestational age 31.5 weeks. 97% were < 72 hours at randomisation. Exclusion criteria: previously received antibiotics, had underlying congenital conditions incompatible with life or were known to be septic. |
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Interventions |
Intervention 1: piperacillin 50 mg/kg and placebo (5% dextrose in water) every 12 hours Intervention 2: ampicillin 50 mg/kg and amikacin 7.5 mg/kg every 12 hours Co‐interventions: not described |
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Outcomes |
Primary outcome
Secondary outcomes
Follow‐up
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used computer‐generated randomised sequence. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as being blinded and used placebo. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear whether outcome assessors were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts. |
Selective reporting (reporting bias) | Low risk | Reported mortality. |
Other bias | Low risk | No other bias observed. |