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Efficacy of physiological seawater nasal irrigation for the treatment of children with SARS-CoV-2 Omicron BA.2 variant infection: a randomized controlled trial

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Abstract

Background

Saline nasal irrigation is an effective therapy for relieving common cold symptoms. This study aimed to investigate and explore the efficacy of physiological seawater nasal irrigation (PSNI) on children with mild and asymptomatic infection with Omicron.

Methods

This randomized controlled trial was conducted in Shanghai, China, and 403 children with mild and asymptomatic infection with Omicron were included. These children were allocated into the PSNI group and the control group. The primary outcome was the duration of viral shedding (DVS), and the secondary outcome was the change in clinical symptoms.

Results

The median age of all participants was 5.59 (6.26) years old. The DVS was significantly shorter in the PSNI group [2.40 (1.13)] than in the control group [3.09 (2.14)] (P = 0.014). The multivariable Cox regression model also showed that patients in the PSNI group had an increased probability of shorter DVS compared with patients in the control group [hazard ratio (HR), 1.27; 95% confidence interval (CI), 1.04–1.55; P = 0.017]. Subgroup analysis suggested that the DVS of patients without full vaccination was significantly reduced in the PSNI group. The proportions of runny nose and stuffy nose were apparently reduced in the first three days in the PSNI group or the control group, but there was no evidence showing that PSNI contributes to the benefit compared with the control group.

Conclusion

PSNI can reduce the DVS of patients with mild and asymptomatic infection with SARS-CoV-2 Omicron BA.2 variant.

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Data availability

The de-identified individual participant dataset used in this article will be made available with publication upon reasonable request.

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Funding

Health and Family Planning Research Project of Pudong New Area Health Committee (PW2021E-06).

Author information

Authors and Affiliations

  1. Department of Respiratory Medicine, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, 1678 Dongfang Road, Pudong District, Shanghai, China

    Ji-Lei Lin, Fen Zhang, Shu-Hua Yuan, Jin-Hong Wu, Jing Zhang, Lei Zhang & Yong Yin

  2. University of British Columbia, Vancouver, Canada

    Yan-Bo Li

  3. Information Technology Department, Shanghai Children’s Medical Center National Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, 1678 Dongfang Road, Pudong District, Shanghai, China

    Yi He

  4. Department of Otorhinolaryngology, Shanghai Children’s Medical Center, School of Medicine, Shanghai Jiao Tong University, 1678 Dongfang Road, Pudong District, Shanghai, China

    Jie Chen

  5. Department of Respiratory Medicine, Sanya Women and Children’s Hospital Affiliated to Hainan Medical College, Hainan Branch of Shanghai Children’s Medical Center, Sanya, China

    Yong Yin

  6. Department of Respiratory Medicine, Linyi Maternal and Child Healthcare Hospital, Linyi, China

    Yong Yin

  7. Shanghai Children’s Medical Center Pediatric Medical Complex (Pudong), Shanghai, China

    Yong Yin

  8. Pediatric AI Clinical Application and Research Center, Shanghai Children’s Medical Center, Shanghai, China

    Yong Yin

Authors
  1. Ji-Lei Lin
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  2. Fen Zhang
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  7. Lei Zhang
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  8. Yi He
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  9. Jie Chen
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Contributions

LJL, ZF, LYB: conceptualization, data curation, formal analysis, writing–original draft. YSH, WJH: data curation. ZJ, ZL: data curation, formal analysis, writing–review and editing. HY, CJ, YY: conceptualization, supervision, writing–review and editing. LJL, ZF, LYB contributed equally to this study. All authors critically reviewed the manuscript. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Corresponding authors

Correspondence to Yi He, Jie Chen or Yong Yin.

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Conflict of interest

No financial or non-financial benefits have been received or will be received from any party related directly or indirectly to the subject of this article.

Ethical approval

The study was approved by the ethics committee of the Shanghai Children's Medical Center and conducted according to the Declaration of Helsinki guidelines (SCMCIRB-K2022036-1).

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Lin, JL., Zhang, F., Li, YB. et al. Efficacy of physiological seawater nasal irrigation for the treatment of children with SARS-CoV-2 Omicron BA.2 variant infection: a randomized controlled trial. World J Pediatr (2023). https://doi.org/10.1007/s12519-023-00749-z

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  • DOI: https://doi.org/10.1007/s12519-023-00749-z

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