Nebulised hypertonic saline (3 %) among children with mild to moderately severe bronchiolitis - a double blind randomized controlled trial

BACKGROUND: To Assess the efficacy of nebulised hypertonic saline (HS) (3 %) among children with mild to moderately severe bronchiolitis. METHODS: Infants aged 6 weeks to 24 months, with a first episode of wheezing and Clinical Severity scores (Arch Dis Child 67:289-93, 1992) between 1 and 8, were enrolled over 4 months duration. Those with severe disease, co-morbidities, prior wheezing, recent bronchodilator and steroid use were excluded. Patients were randomized in a double-blind fashion, to receive two doses of nebulized 3 % HS (Group 1) or 0.9 % normal saline (Group 2) with 1.5 mg of L-Epineprine, delivered 30 min apart. Parents were contacted at 24 h and 7 days. The principal outcome measure was the mean change in clinical severity score at the end of 2 h of observation. RESULTS: A total of 100 infants (mean age 9.6 months, range 2–23 months; 61 % males) were enrolled. Patients in both groups had mild to moderately severe disease at presentation. On an intention-to-treat basis, the infants in the HS group had a significant reduction (3.57 ± 1.41) in the mean clinical severity score compared to those in the NS group (2.26 ± 1.15); [p < 0.001; CI: 0.78–1.82]. More children in the HS group (n = 35/50; 70.0 %) were eligible for ER/OPD discharge at the end of 2 h than those in the NS group (n = 15/50; 30 %; p < 0.001), and less likely to need a hospital re-visit (n = 5/50; 10.0 %) in the next 24 h as compared to the NS group (n = 15/50, 30.0 %; p < 0.001). The treatment was well tolerated, with no adverse effects. CONCLUSIONS: Nebulized 3 % HS is effective, safe and superior to normal saline for outpatient management of infants with mild to moderately severe viral bronchiolitis in improving Clinical Severity Scores, facilitating early Out-Patient Department discharge and preventing hospital re-visits and admissions in the 24 h of presentation. TRIAL REGISTRATION: Clinicaltrials.gov NCTID012766821. Registered on January 12, 2011.