Observational study on the performance of the Narhinel method (nasal aspirator and physiological saline solution) versus physiological saline solution in the prevention of recurrences of viral rhinitis and associated complications of the upper respiratory tract infections (URTI), with a special focus on acute rhinosinusitis and acute otitis of the middle ear.

The aim of this study was to assess the validity of Narhinel method in the prevention of recurrences of viral rhinitis and of any associated sequelae, in particular acute otitis of the middle ear (AOM) and acute rhinosinusitis (AR).This was a prospective observational study, in children aged from two months to two years, observed for five months during the cold season and carried out by family pediatricians (FIMP association) in Friuli Venezia Giulia, Italy. The study enrolled 435 patients. The observed population consisted of two groups: the first one of 238 children treated with Narhinel method and the second one of 197 patients treated only with the physiological saline solution. In compliance with the guidelines of an observational trial, the children were prescribed the therapeutic treatments used as a routine. The patients were recruited for the trial after the responsible parent had signed the informed consent form. The study protocol had been approved by the Ethics Committee of the area of Pordenone. In order to be recruited, patients had to comply with the following criteria: symptoms suggestive of the common cold; age > or =2 months < or =2 years; male and female. Patients presenting one or more of the following characteristics were not included: systemic diseases; congenital nasal obstruction (choanal atresia); infections of the upper and lower respiratory tracts other than common cold; systemic and/or topical use of antibiotics and/or corticosteroids at the moment of recruitment. During the five months of the observation period, all the therapies that the investigators had decided it was necessary to administer had been included and recorded in the CRF. Patients evaluations were carried out for five months. The clinical assessment was performed at baseline (B), in the first week (Fw) and monthly and described as M1 to 5; several clinical parameters were analyzed (anterior and posterior rhinorrhoea, oral respiration, noisy nasal respiration, and nasally transmitted thoracic sounds) and measured by the pediatrician at all examinations from B to M5. Other parameters were derived from the parents' daily observations, recorded in a diary and made note of the quality of sleep, diet and respiration, and the use of any drug during any relapse of acute rhinitis (common cold episode). Recurrence of AOM and AR was assessed by the pediatrician at M1-2-3-4-5. Safety of use was determined using the Italian Health Ministry incident/near incident report sheets for Medical Device and based on diaries where the parents took note of any events which occurred during the observation period. Parental satisfaction and compliance were assessed through a questionnaire given to the parents at the end of the last visit (M5).In the Narhinel group, the mean age was inferior (statistically significant): 8.9 compared to 11.4 months in the physiological saline solution group. The frequency of recurrences from viral rhinitis was very similar in the two groups and a decrease (statistical significant) was observed from M3 through M5 in both groups. Rhinorrhea, oral breathing, and other upper respiratory symptoms, improved in the two groups even if in the Narhinel one the improvement was more prominent during the first two months of observation. There was no difference in the frequency of AR between the groups: at M4 and M5, there was a statistically significant decrease in the frequency of episodes. The frequency of AOM varied in the two groups considering a comparison intra-groups: at M5 the decrease of episodes was statistically significant in the Narhinel group. In Narhinel group, AR and acute AOM seem to be more markedly controlled (frequency) especially for AOM. The frequency of adverse events (AEs) did not vary in the two groups: in the Narhinel one there was a difference (not statistically significant and not clinically relevant) in the number of patients with AEs, especially crying and nasal bleeding. One serious AE was reported in the physiological saline solution group. A 14-month-old child developed laryngospasm which recovered completely after hospital treatment with adrenaline. This event was not related to treatment with saline solution and causality was assessed as "unlikely" by the investigator. In the Narhinel group, one serious event of moderate convulsion febrile in a male patient (age of 0.9) was reported. The causality relationship was assessed by the investigator as improbable. Parents' satisfaction was higher (statistically significant) in the Narhinel group compared to the physiological saline solution alone group.In acute rhinites (common cold) both medical devices are effective nevertheless Narhinel method is valid and shows better results in AOM and AR. Moreover Narhinel method was also more appreciated by parents than physiological saline solution. According to authors' experience, the Narhinel method is safe and its performance is valid in the prevention of AOM and AR in children.