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  • Nirsevimab reduces medically attended RSV-associated lower respiratory tract infection and hospitalisations in healthy pre-term infants

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Key publications in paediatrics: Picket
Nirsevimab reduces medically attended RSV-associated lower respiratory tract infection and hospitalisations in healthy pre-term infants
  1. Sarah Murphy
  1. Department of Paediatrics, Cork University Hospital, Cork, Ireland
  1. Correspondence to Dr Sarah Murphy, Paediatrics, Cork University Hospital, Cork, Ireland; sarah.murphy25{at}hse.ie

http://dx.doi.org/10.1136/archdischild-2020-321141

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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.

    Outcomes

    Primary outcome: Clinically documented, PCR-proven, medically attended respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI).

    Secondary outcome: Hospitalisation for RSV …

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    Footnotes

    • Contributors SM wrote the abstract and commentary.

    • Provenance and peer review Not commissioned; internally peer reviewed.