| Methods |
Multi‐centre randomised placebo controlled trial, not stratified. |
| Participants |
20 infants, BW 500 ‐ 1500g, GA < 34w, age < 72h. 3 centres in the US. December 1992 to Aug. 1994. |
| Interventions |
5 infants received 5 mcg/kg GM‐CSF (Immunex, Seattle, US) IV daily for 7d, 5 infants received 5 mcg/kg GM‐CSF IV twice per d for 7d, 5 infants received 10 mcg/kg GM‐CSF IV daily for 7d, 5 infants received placebo daily for 7d. |
| Outcomes |
Positive blood cultures during the 10d observation period. Mortality to 30d.
The GM‐CSF was well tolerated at all doses administered. One patient receiving 5 mcg/kg twice per day developed grade III disseminated intravascular coagulation secondary to necrotising enterocolitis on day 8. There were no grade III or IV pulmonary, hepatic, or haematologic toxicities. |
| Notes |
Group receiving two IV doses per day were not blind |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
