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Review of: Griffin MP, Yuan Y, Takas T, et al. Single-dose nirsevimab for prevention of RSV in preterm infants. N Engl J Med 2020;383:415–25.
Study design: Randomised clinical trial.
Allocation and blinding: Nirsevimab: placebo, 2:1 ratio. Randomisation was stratified by hemisphere (northern or southern) and by age (≤3 months, >3 months to ≤6 months, or >6 months). Concealment was ensured by using an interactive web response system. Participants, carers and outcome observers were blinded to allocation.
Setting: Multisite international clinical trial including 23 countries from both the northern and southern hemispheres.
Patients: Healthy ex-premature (29 + 0 to 34 = 6 weeks) infants without current indication for palivizumab, and without bronchopulmonary dysplasia, liver, renal or cardiac impairment who were currently aged <1 year (8 months in EU) and entering their first bronchiolitis season.
Intervention: Nirsevimab 50 mg intramuscularly or matching placebo, given once, 2 months before RSV season.
Primary outcome: Clinically documented, PCR-proven, medically attended respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI).
Secondary outcome: Hospitalisation for RSV …
Contributors SM wrote the abstract and commentary.
Provenance and peer review Not commissioned; internally peer reviewed.