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Risk factors for hospitalisation due to respiratory syncytial virus infection in children receiving prophylactic palivizumab


Respiratory syncytial virus (RSV) is a common pathogen that causes extremely severe respiratory symptoms in the first few weeks and months of life. In infants with cardiopulmonary diseases, RSV infections have a significant clinical impact. Palivizumab, a humanised monoclonal antibody for RSV, has been shown to significantly reduce the rate of hospitalisation of high-risk infants diagnosed with RSV. However, we have experienced a significant number of RSV infections in our institution that required hospitalisation or intensive care, despite the administration of palivizumab. This study aimed to analyse the risk factors associated with severe RSV despite the use of palivizumab. We retrospectively reviewed the medical records of 688 patients who visited or were admitted to our hospital and received palivizumab. Thirty-seven (5.4%) patients required hospitalisation for RSV, despite receiving palivizumab. In addition, 31 of these patients (83.8%) required hospitalisation out of season for palivizumab injection. Preterm birth (≤ 28-week gestation), bronchopulmonary dysplasia (BPD), and trisomy 21 were risk factors for RSV-related hospitalisation in infected patients, despite receiving palivizumab. Furthermore, subgroup analysis of 69 patients with RSV revealed that hemodynamically significant congenital heart disease (CHD) was also a risk factor for RSV-related hospitalisation.

Conclusion: Preterm birth (≤ 28 weeks of gestation), BPD, trisomy 21, hemodynamically significant CHD, and CHD requiring surgery or cardiac catheterisation/intervention during infancy could be considered when determining whether year-round administration of palivizumab is appropriate.

What is Known:
• Respiratory syncytial virus causes severe respiratory symptoms in infants, particularly those with cardiopulmonary diseases.
• The use of palivizumab has reduced the rate of hospitalisation of infants diagnosed with RSV. Despite this, the rate of hospitalisation is still high.
What is New:
• We identified that preterm birth (≤ 28-week gestation), bronchopulmonary dysplasia, trisomy 21, and hemodynamically significant congenital heart disease were risk factors for RSV-related hospitalisation, even after receiving palivizumab treatment.
• High-risk infants should be closely monitored and the prolonged use of palivizumab should be considered.

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Fig. 1
Fig. 2



Atrioventricular septal defect


Bronchopulmonary dysplasia


Confidence interval


Congenital heart disease


Intracardiac repair


Mitral stenosis


Mitral valve replacement


Partial anomalous pulmonary venous connection


Pulmonary hypertension


Pulmonary stenosis


Respiratory syncytial virus


Standard deviation


Tetralogy of Fallot


Ventricular septal defect


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We are deeply grateful for our patients and their families who participated in this study. We also thank the medical staff of the Hokkaido University Hospital for their assistance in the collection of data.

Author information




Collected and analysed the patient data: ACN, IS, MS, DS, GI, HY, KC, and AT. Interpreted the patient data: ACN, HS, and KC. Wrote the draft manuscript: ACN. Revised and edited the final manuscript: ACN, KC, AM, and AT. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Atsuhito Takeda.

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Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki. The Institutional Review Board of Hokkaido University Hospital for clinical research approved this study (approval no. 019–0452).

Consent to participate

The requirement for informed consent was waived due to the retrospective nature of the study.

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The requirement for informed consent was waived due to the retrospective nature of the study.

Conflict of interest

The authors declare no competing interests.

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Communicated by Nicole Ritz

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Chida-Nagai, A., Sato, H., Sato, I. et al. Risk factors for hospitalisation due to respiratory syncytial virus infection in children receiving prophylactic palivizumab. Eur J Pediatr (2021).

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  • Respiratory syncytial virus
  • Congenital heart disease
  • Congenital anomaly syndromes
  • Preterm birth