| Methods |
Multi‐centre randomised double‐blind placebo controlled trial, stratified by centre and age at infection onset (< 72, > 72h) |
| Participants |
28 infants with clinical signs of sepsis,
and neutrophils < 5 x 10(9)/l
Sepsis defined as >/= 2 objective clinical signs of sepsis requiring treatment with antibiotics. Microbiological confirmation not an entry criteria.
GA > 25w, BW 500 ‐ 1500g, age < 29d.
4 centres in the UK. Dates not given. |
| Interventions |
13 infants received 10 mcg/kg G‐CSF IV daily for a maximum of 14d or until discontinuation of antibiotics
15 infants received placebo. Both were clear colourless fluids
(Filgrastim, Amgen, Thousand Oaks, CA, US) |
| Outcomes |
Mortality during the 42d from study entry.
Survival to 12m
post‐menstrual age.
Treatment related adverse events (peripheral oedema, bradycardia, anaemia, thrombocytopenia and hyponatraemia) occurred in five placebo treated infants and two infants receiving G‐CSF. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
