Thureen 1999.
| Methods | Quasi‐randomised controlled trial; single centre; USA. Dose schedules were rotated on a monthly basis. | |
| Participants | N = 55. Inclusion criteria were gestational age ≥ 34 weeks, postnatal age < 7 days, Apgar scores of > 4 at 1 minute and > 6 at 5 minutes respectively, urine output > 0.5 ml/kg/hour in the first 24 h of life or > 1 ml/kg/h in the second 24 h of life and absence of inotropic support. 'Once a day' gentamicin: N = 27. 'Multiple doses a day' gentamicin: N = 28. Mean gestational age in 'once a day' gentamicin group was 37.8 ± 2.1 weeks vs 36.9 ± 2.6 weeks in 'multiple doses a day' group. Mean BW in 'once a day' group was 2831 ± 613 g vs 2795 ± 714 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 intravenous infusion over 30 min. All patients received ampicillin concomitantly. | |
| Outcomes | The peak serum gentamicin level was measured 30 min after completion of the infusion on day three of therapy (fifth dose of 'multiple doses a day' and third dose of 'once a day' gentamicin group). Trough levels were measured immediately before the administration of the dose on day three of therapy (fifth dose of 'multiple doses a day' and third dose of 'once a day' gentamicin group). Other outcome measured was cost of therapy. | |
| Notes | Additional information and methodology were clarified by the authors. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quasi‐randomised trial; dose schedules were rotated on a monthly basis. |
| Allocation concealment (selection bias) | High risk | Allocation to a particular study group was open to investigators. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | "Cost of labor was determined by time‐in motion observations of gentamicin‐associated tasks". Lack of blinding may have influenced cost‐effectiveness analyses. But serum gentamicin concentration measurement unaffected by blinding. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All 55 patients analysed. |
| Selective reporting (reporting bias) | Low risk | All prespecified primary outcomes reported. |
| Other bias | Low risk | Appears to be free of other biases. |
BW = birth weight h = hour min = minute vs = versus