EUCTR 2018‐002980‐25‐IT.

Methods	Parallel group, randomised, multicentre, open‐label study
Participants	Newborns until 6 months of age
Interventions	Palivizumab (dosage not reported) versus placebo
Outcomes	Primary outcomes Overall respiratory morbidity (composite primary endpoint), whose definition is: ‐ LRTIs by any pathogen (including, but not limited to, RSV) + ‐ recurrent wheezing (quantified as the presence of wheezing days and/or need for use of antiwheezing drugs) +/‐ asthma Secondary outcomes Difference of RSV‐related hospitalisation due to LRTI during the first RSV‐season (November 1st to March 31th) between Group A (treated with palivizumab) and Group B (not treated). Direct costs in terms of difference of health resources used by Group A and Group B respectively and related to: ‐ length of hospitalisations (days); ‐ mechanical ventilation and other support therapies (type, number, duration); ‐ ICU admission and length of stay (days); ‐ outpatient visits (type and number of specialistic visits); ‐ drugs (type, dosages and therapy duration); and ‐ diagnostic tests (type and number). Costs for resources used will be calculated using National Health Service tariffs. Indirect costs in terms of loss of working days for parents due to child illness.
Notes	Insufficient information on the trial record to determine inclusion as an ongoing trial.