| Methods |
Quasi‐randomised controlled trial using alternate group assignment. Placebo was not used.
Allocation concealment: no
Blinding of intervention: no
Completeness of follow up: yes
Blinding of outcome measurement: no |
| Participants |
Single unit study in Montreal, Canada. Subjects recruited from 1 April 1971 to 31 March 1972. Infants with respiratory distress syndrome and having umbilical arterial catheters inserted were considered eligible for inclusion. Catheters were inserted under sterile conditions, within 24 hours of birth. There were 37 infants in the treatment group and 38 in the control group. Birth weight range was 720 ‐ 3500 grams and gestational age at birth ranged from 25 to 40 weeks. |
| Interventions |
Ampicillin 25 mg/kg intravenously every 6 hours plus kanamycin 7.5 mg/kg intramuscularly every 12 hours versus no treatment. At catheter insertion and daily thereafter 1.5‐3 mL of blood for culture was collected from the catheter. Just prior to catheter removal, blood for culture was collected from a cleansed peripheral site on an upper limb (or in the event of death, via a cardiac puncture) and from the catheter. The distal 1‐2 cm of catheter was collected for culture in 33 treated infants and 35 control infants. The following organisms were considered contaminants: coagulase‐negative Staphylococci, Micrococcus species, alpha‐haemolytic Streptococcus, and diphtheroids. |
| Outcomes |
Mortality: 11 of 37 treated infants and 10 of 38 control infants died. All deaths were judged to be due to hyaline membrane disease. Catheter‐drawn blood cultures just prior to catheter removal: positive in 8 of 37 treated infants (all considered contaminants) and 19 of 38 control infants (16 considered contaminants). Peripherally‐drawn blood cultures: positive in no treated infants and 3 of 38 control infants (one considered a contaminant). Of the two considered pathogens, one was Pseudomonas aeruginosa and the other was Staphylococcus aureus. The Pseudomonas was isolated from a post‐mortem cardiac puncture specimen, and also from a catheter‐drawn specimen collected prior to the infant's death. It was not isolated from the catheter tip, and blood cultures (both catheter‐drawn and peripherally‐drawn) 24 hours prior to death were negative. The Staphylococcus aureus was isolated in a blood culture specimen drawn 2 days after catheter removal. Catheter‐tip colonisation: organisms were isolated from the tips of catheters of 8 of 33 treated infants (6 were considered contaminants) and 19 of 35 control infants (13 were considered contaminants). Two infants (one from each group) had localised umbilical infection. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
High risk |
Quasi‐randomised controlled trial using alternate group assignment. Placebo was not used. |
| Allocation concealment? |
High risk |
Allocation concealment: no |
| Blinding?
All outcomes |
High risk |
Blinding of intervention: no
Blinding of outcome measurement: no |
| Incomplete outcome data addressed?
All outcomes |
Unclear risk |
Completeness of follow up: yes |
