Cairo 1999.

Methods	Multi‐centre randomised double‐blind placebo controlled trial, stratified by centre and BW (501 ‐ 750, 751 ‐ 1000g).
Participants	264 infants without evidence of infection, BW 501 ‐ 1000g, all AGA (small for gestation infants excluded), age < 72h. Neutropenia not an entry criteria. 12 centres in the US. February 1995 to April 1997.
Interventions	134 infants received 8 mcg/kg GM‐CSF IV daily for 7d then every other day for an additional 21d, Treatment discontinued If WBC > 20 or if venous access no longer available 5% of treated infants needed a "dose reduction" (unspecified) GM‐CSF (Immunex, Seattle, US) 130 infants received placebo.
Outcomes	Incidence of "confirmed nosocomial infections"* during treatment (ie to day 28 from trial entry). Mortality to 28d. Infants followed to day 58 but outcomes at that time not reported. * Infection incidence (as defined by authors) during treatment. No grade III/IV toxicity (National Cancer Institute common toxicity criteria) or adverse events were associated with GM‐CSF. No further details given
Notes	Criteria for diagnosing "Confirmed nosocomial sepsis"*: One or more of: 1. Positive blood culture: Single positive for pathogenic bacteria, Positive on 2 occasions 4 days apart for commensal organisms. 2. Positive urine culture: Suprapubic or urethral catheter 3. Positive CSF 4. Positive culture from bone abscess or pleura 5. Radiological evidence of NEC Incidence distribution of these criteria or organisms not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear