| Methods |
Randomised, controlled, sequential clinical trial, with evaluations every two months. Method of randomisation is unknown. Not blinded.
Blinding of randomisation (allocation concealment): can't tell
Blinding of intervention: no
Completeness of follow up: yes
Blinding of outcome measurement: no |
| Participants |
Single neonatal intensive care unit trial in Gottingen, Germany from August 1990 to November 1992. Infants having central venous catheters (all small‐diameter silicone) were considered eligible. Exclusion criteria are not stated. There were 148 infants (75 in the treatment group, 73 in the control group) recruited. Range of gestational age and birth weight is not stated. For each patient, only the initial catheter inserted was included in the data analysis. |
| Interventions |
Treatment Group; amoxicillin 100 mg/kg/day intravenously in three divided doses (n=75).
Control Group; no treatment (n=73). Placebo was not used. |
| Outcomes |
Mortality ‐ timing of the death is not reported.
Proven bacterial septicaemia.
Suspected bacterial septicaemia or clinical septicaemia. |
| Notes |
We attempted, unsuccessfully, to contact the first author for further details and data. Catheters were used for administration of parenteral nutrition and all infants had heparin (1 unit/mL; minimum 50 units/day) added to the infusate. The catheters were removed when no longer required for parenteral nutrition administration, or when there were signs of serious infection, blockage or dislodgement. The catheter tip was sent for bacterial culture on removal. Twice weekly, a drop of fluid from the connecting hub was sent for bacteriologic examination. Leucocyte count, immature:total (I:T) neutrophil ratio, thrombocyte count and CRP were measured twice weekly and when clinically indicated. Catheter‐related septicaemia was defined as presence of clinical signs (apnoea, bradycardia, temperature instability, feeding problems, circulatory changes, lethargy), suspect laboratory findings (CRP >0.6 mg/dL; I:T ratio >0.16), and identical bacterial growth in peripheral vein blood culture and catheter tip. Suspected catheter‐related septicaemia was defined as presence of clinical signs and suspect laboratory findings but negative blood culture. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
