| Methods |
Randomised controlled trial; single centre; India |
| Participants |
N = 18. Inclusion criteria were neonates requiring gentamicin therapy as per unit protocol, 32 to 36 weeks' gestation, < 96 h of age, and serum creatinine < 1 mg/dl. 'Once a day' gentamicin: N = 9.
Multiple doses a day' gentamicin: N = 9. Mean gestational age was 34.1 ± 1.5 weeks in 'once a day' gentamicin group and 34.0 ± 1.9 weeks in 'multiple doses a day' group. Mean BW in 'once a day' group was 1940 ± 510 g and 1739 ± 527 g in 'multiple doses a day' group. |
| Interventions |
'Once a day' gentamicin group were given gentamicin at 4 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 1‐min bolus intravenously followed by normal saline flush of 0.5 ml. |
| Outcomes |
Peak levels were collected 1 hour after the first dose and the dose given at 48 h. Trough levels were collected just prior to the dose of gentamicin due at 48 h after the start of the therapy. Other outcomes measured were serum creatinine. |
| 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 |
All 18 neonates were included in the results. |
| Selective reporting (reporting bias) |
High risk |
"There was no nephrotoxicity in either groups at the end of therapy." There was no pre‐specified analysis method to measure nephrotoxicity in the methodology. |
| Other bias |
Low risk |
Appears to be free of other sources of bias. |
