title: Topical administration of hyaluronic acid in children with recurrent or chronic middle ear inflammations.
abstract: Hyaluronic acid (HA) treatment has been successfully performed in patients with recurrent upper airway infections or rhinitis. The aim of this study was to assess the efficacy and safety of the topical nasal administration of an HA-based compound by investigating its effects in children with recurrent or chronic middle ear inflammations and chronic adenoiditis. A prospective, single-blind, 1:1 randomised controlled study was performed to compare otoscopy, tympanometry and pure-tone audiometry in children which received the daily topical administration of normal 0.9% sodium chloride saline solution (control group) or 9 mg of sodium hyaluronate in 3 mL of a 0.9% sodium saline solution. The final analysis was based on 116 children (49.1% boys; mean age, 62.9 ± 17.9 months): 58 in the control group and 58 in the study group. At the end of follow-up, the prevalence of patients with impaired otoscopy was significantly lower in the study group (P value = 0.024) compared to baseline but not in the control group. In comparison with baseline, the prevalence of patients with impaired tympanometry at the end of the follow-up period was significantly lower in the study group (P value = 0.047) but not in the control group. The reduction in the prevalence of patients with conductive hearing loss (CHL) (P value = 0.008) and those with moderate CHL (P value = 0.048) was significant in the study group, but not in the control group. The mean auditory threshold had also significantly improved by the end of treatment in the study group (P value = 0.004) but not in the control group. Our findings confirm the safety of intermittent treatment with a topical nasal sodium hyaluronate solution and are the first to document its beneficial effect on clinical and audiological outcomes in children with recurrent or chronic middle ear inflammations associated with chronic adenoiditis.
authors.affiliation: Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy sara.torretta@gmail.com.
authors.forename: Sara
authors.initials: S
authors.lastname: Torretta
authors.affiliation: Department of Maternal and Pediatric Sciences, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Marchisio
authors.affiliation: Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Rinaldi
authors.affiliation: Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Gaffuri
authors.affiliation: Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Pascariello
authors.affiliation: Clinical Chemistry and Microbiology Laboratory, IRCCS Galeazzi Institute, Milan, Italy LITA Clinical Microbiology Laboratory, L. Sacco Department of Clinical Science, Università degli Studi di Milano, Milan, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Drago
authors.affiliation: Department of Maternal and Pediatric Sciences, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Baggi
authors.affiliation: Department of Clinical Sciences and Community Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Pignataro
mesh_terms: D000281:Administration, Intranasal; D000287:Administration, Topical; D001301:Audiometry, Pure-Tone / Q000379:methods; D001309:Auditory Threshold / Q000187:drug effects; D016022:Case-Control Studies; D002675:Child, Preschool; D002908:Chronic Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D008297:Male; D010031:Otitis / Q000188:drug therapy*; D011446:Prospective Studies; D016037:Single-Blind Method
chemical_list: D006820:Hyaluronic Acid
keywords: adenoids; children; otitis