| Methods |
Randomised controlled trial; single centre; Germany |
| Participants |
N = 20. Inclusion criteria were neonates with pneumonia, meconium aspiration, suspected bacterial sepsis, and premature rupture of membranes > 36 h before delivery. Exclusion criteria were gestational age < 37 weeks, BW < 2500 g, Apgar score of ≤ 4 at 1 minute and ≤ 6 at 5 minutes, serum creatinine > 85 micromol/l and those requiring diuretics during the course of treatment and those who were exposed to aminoglycoside prenatally. 'Once a day' gentamicin: N = 10.
'Multiple doses a day' gentamicin: N = 10. Mean gestational age in 'once a day' gentamicin group was 39.5 ± 1.4 weeks vs 40.3 ± 0.8 weeks in 'multiple doses a day' group. Mean BW in 'once a day' group was 3300 ± 600 g vs 3800 ± 600 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 mg/kg/dose every 12 h. Gentamicin was given as intravenous infusion over 30 min. All infants were treated with ampicillin concomitantly. |
| Outcomes |
The pharmacokinetic profile of gentamicin was determined on the fourth day of treatment. Outcomes measured were peak levels, trough levels and area under the concentration time curves, urinary excretion of alanine aminopeptidase as a marker of nephrotoxicity. |
| 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) |
Unclear risk |
Insufficient information to allow a definite judgement. |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Outcome measures unlikely to influence outcome measures. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No missing outcome data. |
| Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes reported. |
| Other bias |
Low risk |
Appears to be free of other biases. |
