| Methods |
Randomised controlled trial; single centre; USA |
| Participants |
N = 44. Infants with BW ≥ 2500 g, age ≤ 7 days, Apgar scores of ≥ 5 at 5 minutes, suspected systemic or focal bacterial infection. Exclusion criteria were history of perinatal asphyxia, shock or cardiorespiratory arrest, seizures, anomalies of the kidney or major congenital anomalies incompatible with life and evidence of neuromuscular disorder. 'Once a day' gentamicin: N = 20.
'Multiple doses a day' gentamicin: N = 21.
3 infants excluded after enrolment. Mean BW 3302 ± 674 g in 'once a day' vs 3387 ± 526 g in 'Multiple doses a day' gentamicin group. All infants were enrolled within the first 24 h after birth. |
| 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 infused over a period of 30 min with a metered syringe pump using micropore tubing.
All infants were treated concomitantly with ampicillin. |
| Outcomes |
Blood for peak serum gentamicin was drawn 30 min after completion of the gentamicin infusion; and for trough concentration, 30 min prior to the start of gentamicin infusion. Trough and peak SGCs drawn with the dose at 48 h were considered to reflect steady state. Other outcomes that were measured were urine output, serum creatinine, creatinine clearance and hearing screen test prior to discharge. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer generated numbers |
| Allocation concealment (selection bias) |
Low risk |
Using sealed envelopes |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Measurement of peak and trough level are unaffected by knowledge of types of dosing regimen |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Only three infants were excluded after enrolment |
| Selective reporting (reporting bias) |
Low risk |
Predetermined outcome measures reported |
| Other bias |
Low risk |
Appear to be free of other source of biases |
