Randomized, prospective, single-center, open study on preventing RSV-mediated respiratory sequelae in preterm newborns

Respiratory Syncytial Virus (RSV) is a common cause of lower respiratory tract infections and infant hospitalizations. Palivizumab (PVZ) is recommended for high-risk infants during bronchiolitis seasons to prevent severe infections. The aim of our study was to assess the impact of PVZ on the development of RSV-caused short- and long-term respiratory morbidity. Healthy preterm infants under 6 months at the RSV season onset were enrolled and randomly assigned to Group A, who received PVZ, and Group B, who did not receive PVZ. A sub-analysis was also performed based on birth weight, breastfeeding, and family history of atopy. Regular follow-up visits occurred until the 80th week, evaluating short-term (hospitalizations) and long-term (outpatient visits for respiratory illnesses and wheezing) complications. 46 infants were included: group A: 25 infants, 52% female, mean age 4.3 (±1.7) months and gestational age of 33 (±1.8) weeks; group B: 22 infants, 64% male, mean age of 2.9 (±1.5) months and gestational age of 34.8 (±1.4) weeks. Group B experienced a significantly higher risk of RSV-related hospitalizations, co-infections, outpatient visits for acute respiratory illnesses and wheezing episodes than Group A (p. 000,. 005,. 036 and. 000, respectively). Antibiotics, corticosteroids, anti-asthmatic, and anti-reflux therapies did not reach statistical significance among the two groups. Patients in group B with a birth weight < 2170 g had a higher risk of RSV-related hospitalizations, co-infections, and need for antibiotics and corticosteroids (p. 036,. 040,. 036 and. 036, respectively). PVZ resulted effective in preventing short- and long-term respiratory morbidity.