NASAL INFECTION Kids
RHINITIS, RHINOSINUSITIS & NASAL CONGESTION
Most nasal infections in children start as initial virus infection. The virus grows and liberates a huge quantity of virions on the nasal mucosa, which in turn infect new cells, causing multiple minute injuries & inflammation, followed by secondary bacterial infection and the symptoms of rhinitis. Infection invasion into the paranasal sinuses leads to rhinosinusitis (RS) with sinus swelling & blockage of sinus openings.
Rhinovirus infection is more common in children, compared to influenza in adults, with less inflammation, basement membrane thickening, and mucus gland hyperplasia. Infections progress faster in kids, and are accompanied by severe sinus pain, fatigue, fever, uneasiness & poor sleep.
Ideal Treatment Approach for children:
Treating nasal infections effectively in children requires a treatment which is: (1) Easy to apply; (2) Fast acting; (3) Able to remove bacteria and viruses & prevent further virus multiplication; and (4) to re-establish normal sinus drainage rapidly. An ideal treatment should also be free of side effects, non-chemical to allow rapid healing of the damaged nasal mucosa, and totally non-irritant.
A specific Medical Device for the treatment of Nasal infections (Rhinitis, Rhinosinusitis and Nasal Congestion) in Children
Currently Available Treatments:
RS being a complex & pluri-pathology, there is no specific treatment for RS in children. Nasal wash with saline solution is the most commonly used treatment. 9/10 currently available treatments are OTCs, symptomatic, and mono-target. Topical antivirals such as Acyclovirs & Tamiflu act intracellularly (while virus is present on the surface of the nasal mucosa) & have undesirable effects. They are not used in children due to poor benefit/risk ratio.
VITROBIO’s Completely NEW Therapeutic Approach:
The aim of VITROBIO’s research was to find a fast-acting, safe & topical nasal treatment which is adapted for children. In topical virus infections, most virus particles are present on the biological surface. The virus attaches to the cells through specific surface Glycoproteins (GPs) such as the Hemagglutinin & Neuraminidase (H1N1, H6N9) on the flu virus, continues infecting new cells from outside and maintaining the infection. Vitrobio conceived a filmogen glycerol based sprayable liquid dressing that is 18 times more osmotically active than sea water yet NON-IRRITANT (International patent 1997: PCT/FR99/01340 and PCT/EP2013/061835).
Spraying Nesospray-Kids on the nasal mucosa instantly forms a film, attracts hypotonic liquid, breaks the biofilm within 15-20 min, opens & drains sinuses, relieves intra-sinusal pressure & reduces pain. The strong hypertonic activity of the product mechanically cleans the surface by detaching and draining all contaminants from the nasal mucosa, including bacteria and virus particles, which are eliminated with the outflow of hypotonic liquid (nasal discharge). Nesospray-Kids helps to stop further infection and reduces the need for antibiotics. Being topically active, the product is totally safe with no side-effects. (For detailed mode of action: please contact Vitrobio)
Product presentation: 15mL spray
Posology: 2-3 sprays in each nostril, 2-3 times per day until complete recovery.
Regulatory Status: Due to the mechanical topical filmogen activity without any pharmacological, biological, metabolic or immunological interaction with the cellular structure: Class I Medical Device in Europe.
Contraindications: Not to be used in pediatric population under 3 years of age.
Side Effects: This product has no known side effects.
Clinical Efficacy:
A comparative, randomized, double-blind, parallel group, observational clinical trial study was conducted at Malons Multispeciality Hospital and ICU (Navi Mumbai/India) to evaluate the efficacy and safety of Vitrobio Rhinosinusitis spray for Kids versus 0.9% NaCl saline solution spray in the treatment of acute or chronic rhinosinusitis. Dates of the study: 18/09/2018-25/10/2018 (5 weeks). 30 patients aged 3-16 years old. Study number: NESO-E/OBS/2018. The results of the study clearly show that the test product is highly effective in suppressing the symptoms of rhinosinusitis in children (rhinorrhea or congestion, fever, cough, lack of good sleep, pain upon facial pressure). No adverse side effects were reported in any of the groups.
