Table 1.

REGAL: study questions

1. What is the overall epidemiology and disease burden of severe RSV infection in Western countries, and what are the associated risk factors for RSVH? 2. What is the predisposition and associated morbidity, long-term sequelae and mortality of preterm infants (<37 wGA) without CLD/BPD or CHD, overall, and split by gestational age segments, to severe RSV infection, and what are the risk factors associated with RSVH? 3. What is the predisposition and associated morbidity, long-term sequelae and mortality of infants with underlying CLD/BPD to severe RSV infection in Western countries? 4. What is the predisposition and associated morbidity, long-term sequelae and mortality of infants with underlying CHD to severe RSV infection in Western countries? 5. What is the nature, incidence and impact of long-term respiratory morbidity associated with RSVH in infancy in Western countries, specifically early and late wheeze? 6. What other groups of infants with underlying medical conditions or chronic diseases are at high risk of RSVH and associated morbidity? 7. What are the optimal approaches and strategies for the prevention and treatment of severe RSV infection and what are the future perspectives in this regard?

BPD bronchopulmonary dysplasia, CHD congenital heart disease, CLD chronic lung disease, RSV respiratory syncytial virus, RSVH RSV hospitalization, wGA weeks’ gestational age