Aim: The aim of this study was to assess the safety, effectiveness and parental compliance with a medical device on the market in Europe for removing excess nasal secretions by aspiration in babies viral infections of the upper respiratory tract.
Methods: A prospective observational noncomparative cohort study, as part of postmarketing and customer satisfaction surveillance was specifically performed among family paediatricians in Lombardy, Italy. Two hundred and forty patients were admitted from 22 different family pediatricians belonging to the Italian Federation of Paediatricians (Federa-zione Italiana Medici Pediatri, FIMP) in Lombardy. All patients took part in the safety assessment. Two hundred and twelve patients (104 females, 108 males, average age 9.6 months, age range 1.8-27.6 months) also underwent clinical efficacy assessment (28 patients were excluded). Upon admission and at the first outpatient examination (E1), parents were taught by their family pediatrician to clean their babies' noses by nasal aspiration 3 times a day for 7 consecutive days immediately before feeding. At the end of treatment, a second outpatient examination (E2) was carried out at which parents' treatment diaries were collected and the parents answered a satisfaction questionnaire. SAFETY of use was checked using: 1) Italian Health Ministry incident/near incident report forms and 2) treatment diaries where the parents noted any events that had occurred while using the device every day. EFFICACY was assessed by analysing various clinical parameters (anterior and posterior rhinorrhea, oral respiration, noisy nasal respiration, and nasally transmitted chest sounds) measured by the pediatrician at the two examinations (E1 and E2), and the entries in the parents' treatment diary regarding quality of sleep, feeding and respiration, and use of any drugs. Parental satisfaction and compliance were assessed through a questionnaire given to the parents at E2. The device is marketed in 2007 under the name of Narhinel in Italy, Spain and Portugal; Otrisalin in Greece; Prorhinel in France; Rhinomer in the Baltic countries (Lithuania, Latvia, Estonia); Otrivin Baby in Russia and Otri-Baby in Sweden.
Safety: no incidents were reported to the Italian Ministry of Health. There were 40 cases of mild side effects such as nose bleed (6), protracted crying (30), restlessness/irritation (2), vomiting and others (2).
Efficacy: clear improvements were seen in all the clinical parameters assessed at the post-treatment examination (E2) when compared to E1: anterior rhinorrhea (decreased by 74%), posterior rhinorrhea (decreased by 80%), oral respiration (decreased by 78%), noisy respiration (decreased by 73%), and nasally transmitted chest sounds (decreased by 82%). The entries in the treatment diaries also showed progressive improvement in the children's' conditions during the treatment period: peaceful sleep increased by 67%, quality of feeding increased by 36%, respiration improved by 76%, and the administration of drugs decreased by 41%. The P values for each item (clinicians observations and parents' observations) are statistically significative P<0.001, between the day 1 and the day 8. Satisfaction and compliance were excellent: 92% of parents were satisfied (56% very and 42.7 fairly). Seventy-eight percent reported that the device was simple to use, and 86% of parents judged Narhinel to be more effective than other similar devices.
Conclusion: Narhinel proved to be a safe, effective and simple to use device. The parents of babies with nasal obstruction caused by upper respiratory infection were extremely satisfied.