Efficacy and safety of seawater-based nasal irrigation on nasal congestion in infants and toddlers with common cold: a randomized controlled trial.

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 ).