TY  - JOUR
AU  - Giordano P
AU  - Boggio V
AU  - Sensini M
AU  - Nadalin J
AU  - Pecorari G
AU  - Tavormina P
PY  - 2025
DA  - 2025/10/30
TI  - Pilot Observational Study on the Use of Narlisim in Children Under Three Years of Age with Nasal Obstruction and a History of Acute Otitis Media
JO  - Archives of Clinical Trials
VL  - 5
IS  - 2
AB  - Nasal irrigation, by mechanically removing secretions and liquefying mucus, allows children to
improve nasal breathing, with a significant impact on quality of life and reduction of comorbidities.
Evidence supports its use as a safe and reasonably effective practice in managing nasal symptoms even
in children under 36 months of age. In our uncontrolled observational study, we evaluated the safety
profile of Narlisim, a medical device based on a hypertonic saline solution with moderately acidic pH
and osmoprotective activity for nasal use, in children under 36 months of age during one month of
continuous use. Despite their young age, in which allergic reactions to topical nasal applications can
occur more frequently than in adults, no adverse events attributable to the use of this medical device
were observed after one week (T1) or one month (T2) of treatment. Moreover, the use of Narlisim proved
to be statistically effective in controlling nasal symptoms such as obstruction and rhinorrhea, and also
demonstrated significant improvement in rhinoscopic findings. Given the small sample size and the
study design, further controlled randomized studies with larger populations are needed to confirm our
observations.
SN  - 2768-4598
UR  - https://dx.doi.org/10.33425/2768-4598.1055
DO  - 10.33425/2768-4598.1055