BACKGROUND Respiratory syncytial virus (RSV) infection causes acute lung infection in infants and young children worldwide, resulting in considerable morbidity and mortality. Children with cystic fibrosis (CF) are prone to recurrent lung inflammation, bacterial colonisation and subsequent chronic airway disease, putting them at risk for severe RSV infections requiring intensive care and respiratory support. No treatment currently exists, hence prevention is important. Palivizumab is effective in reducing RSV hospitalisation rates and is recommended for prophylaxis in high-risk children with other conditions. It is unclear if palivizumab can prevent RSV hospitalisations and intensive care unit admissions in children with CF. OBJECTIVE To determine the efficacy and safety of palivizumab (Synagis((R))) compared with placebo, no prophylaxis or other prophylaxis, in preventing hospitalisation and mortality from RSV infection in children with CF. METHODS We searched the Cochrane CF and Genetic Disorders Group Trials Register and scanned references of the eligible study and related reviews.Last search: 20 January 2010. METHODS Randomised and quasi-randomised studies. METHODS The authors independently extracted data and assessed risk of bias. RESULTS One study (186 infants up to two years old) comparing five monthly doses of palivizumab (N=92) to placebo (N=94) over one RSV season was identified and met our inclusion criteria. At six months follow-up, one participant in each group was hospitalised due to RSV; there were no deaths in either group. In the palivizumab and placebo groups, 86 and 90 children experienced any adverse event, while 5 and 4 children had related adverse events respectively. Nineteeen children receiving palivizumab and 16 receiving placebo suffered serious adverse events; one participant receiving palivizumab discontinued due to this. At 12 months follow-up, there were no significant differences between groups in number of Pseudomonas bacterial colonisations or change in weight-to-height ratio. CONCLUSIONS We identified one randomised controlled trial comparing five monthly doses of palivizumab to placebo in infants up to two years old with CF. While the overall incidence of adverse events was similar in both groups, it is not possible to draw conclusions on the safety and tolerability of RSV prophylaxis with palivizumab in infants with CF because the trial did not specify how adverse events were classified. Six months after treatment, the authors reported no clinically meaningful differences in outcomes; however no data were provided. Additional randomised studies are needed to establish the safety and efficacy of palivizumab in children with CF.