An epidemiological investigation of high-risk children for Respiratory Syncytial Virus infections - RWE palivizumab utilization as a RSV preventive treatment in Lazio (Italy)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Respiratory tract infection

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  8000

Study design details

• Main study objective:
  The overall objective of the study will be to perform a descriptive analysis of a series of aspects related to respiratory syncytial virus infection in high-risk children, such as drug utilization, hospitalizations and related hospital procedures.
• Outcomes:
  1. Palivizumab utilization (presence or absence of palivizumab prophylaxis, number of prescriptions, adherence) 2. In children with Bronchopulmonary Dysplasia, Congetinal Heart Disease and in preterm populations, describe the health-care resource utilization up to 24 months after birth: hospitalizations, related hospital procedures and drug consumption
• Data analysis plan:
  Descriptive analysis will be performed on three different cohorts of high-risk children for RSV severe infection (children with BPD, children born with CHD and children born preterm (≤29 and 30-35 WGA). All infants will be observed from index date (date of birth will be defined as index date) until the end of follow-up (maximum 24 months after birth day), end of study. Descriptive statistics will be defined by cohort and per year of birth and stratified by palivizumab use and WGA (according to data availability). Categorial variables will be presented as counts and percentages, while continuous variables will be presented as mean and standard deviation or median and interquartile range according to data distribution. Incidence and prevalence of hospitalizations for each RSV season will be calculated.