Kosalaraksa 2004.

Methods	Randomised controlled trial; single centre; Thailand.
Participants	N = 64. Inclusion criteria were BW ≥ 2000 g, age ≤ 7 days, Apgar score of > 6 at 5 min and suspected sepsis. Exclusion criteria were history of perinatal asphyxia, shock, cardiopulmonary arrest, seizure, neuromuscular disorder or anomalies of kidney or ear. 'Once a day' gentamicin: N = 33. 'Multiple doses a day' gentamicin: N = 31. Mean gestational age in 'once a day' gentamicin group was 38.4 ± 1.8 weeks vs 38.6 ± 2.1 weeks in 'multiple doses a day' group. Mean BW in 'once a day' group was 3044 ± 475 g vs 3036 ± 497 g in 'multiple doses a day' group.
Interventions	'Once a day' gentamicin group were given gentamicin at 5 mg/kg/dose once every 24 h. 'Multiple doses a day' gentamicin group were given gentamicin at 2.5 mg/kg/dose every 12 h. Gentamicin was given as intravenous infusion over 60 min.
Outcomes	The peak serum gentamicin level was measured 30 min after infusion (after the 3rd dose in 'once a day' group and the 6th dose in the 'multiple doses a day' group. Trough levels were measured immediately before the 4th dose in 'once a day' group and the 7th dose in the 'multiple doses a day' group. Other outcomes that were measured were urine output, serum creatinine on day 0, 3 and 7 or on the discontinuation day.
Notes	Additional information and methodology were clarified by the authors.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random numbers.
Allocation concealment (selection bias)	Low risk	Sealed envelopes.
Blinding (performance bias and detection bias) All outcomes	Low risk	Outcome assessors were blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Only 3 out of the 64 study infants did not have blood levels of gentamicin measured.
Selective reporting (reporting bias)	High risk	"serum creatinine was measured on days 0, 3 and 7 or discontinuation day": statistical method to compare was not pre‐specified. "The authors evaluated the clinical response using inclusion point of "improvement within 72 hours of treatment": method to define "improvement within 72 hour of treatment" not pre‐defined.
Other bias	Low risk	Appears to be free of other sources of bias.