European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery
September 16, 2026 · via Europe PMC
Efficacy and safety of seawater-based nasal irrigation on nasal congestion in infants and toddlers with common cold: a randomized controlled trial.
Chen O, Prime C, Hooper W, Vanderzande T, Alegre M, Rynkiewicz A, Karpińska-Nowak A, Ghassemi A.
AI summary — for doctors, generated from the abstract only
Adding a hypertonic seawater nasal spray to standard care improved nasal congestion and cold recovery in infants and toddlers in a randomized trial.
What was studied
An open-label randomized controlled trial of 220 children aged 3-48 months with the common cold, comparing standard care with or without a copper- and manganese-enriched hypertonic seawater nasal spray over 10 days.
Key findings
- Nasal spray users experienced significant improvement in outcomes (specific statistics not fully captured in the abstract)
- Authors report rapid congestion relief, improved recovery rates and good safety
Clinical relevance
Suggests the spray may be a reasonable adjunct for congestion in young children with colds, though the open-label, questionnaire-based design may favour the intervention.
Who should care
Limitations
Open-label design with caregiver-reported outcomes, susceptible to reporting bias.
Seawater nasal spray appears to ease cold congestion in young children.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
Background
Nasal congestion associated with the common cold is a frequent source of distress in infants and toddlers. While hypertonic seawater solutions offer a physiological mechanism for decongestion via osmosis, robust clinical evidence supporting their use as an adjunct to standard care in this specific pediatric population is essential to validate their therapeutic value.
Objective
To evaluate the efficacy and safety of a hypertonic seawater nasal spray enriched with copper and manganese combined with standard of care compared to standard of care alone in alleviating nasal congestion, improving sleep quality, and accelerating symptom recovery in infants and toddlers aged 3-48 months experiencing the common cold without high fever (excluding acute rhinosinusitis).
Methods
In a randomized, open-label, controlled parallel study, 220 participants received standard care (which included ample hydration, at-home rest, and the use of paracetamol as needed) with or without the nasal spray. Outcomes, including symptom severity, recovery rate, sleep quality, secondary infections, and caregiver satisfaction, were assessed via questionnaires over 10 days.
Results
Participants using the nasal spray experienced a significant (p < 0.05) reduction in nasal congestion from the evening of Day 0 through Day 5, with immediate symptom relief observed within 5-15 min of application. By Day 10, recovery rates were higher in the nasal spray group (75.3% vs. 58.5%). Improvements in cough and runny nose severity were significant, though minimal effects were noted for other symptoms. Sleep quality and secondary infection rates were comparable between groups. Caregivers expressed high satisfaction, with 93.6% willing to use the product again. No adverse events were linked to the nasal spray.
Conclusion
The hypertonic seawater solution nasal spray is a safe and effective adjunct to standard care, providing rapid relief of nasal congestion and improving cold recovery rates in young children. Trial registered at ClinicalTrials.gov: NCT05365789 ( https://clinicaltrials.gov/search?cond=NCT05365789 ).
DOI
10.1007/s00405-026-10615-z
PMID
42747526
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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