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

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
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.
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
Outcomes Primary outcome
  • All‐cause mortality


Secondary outcomes
  • Mortality due to infection

  • Duration of treatment

  • Renal impairment (nephrotoxicity) defined as > 100 μmol/L

  • Hepatic impairment defined as total serum bilirubin > 20 μmol/L


Follow‐up
  • Not described

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.