Abstract
BackgroundTo Assess the efficacy of nebulised hypertonic saline (HS) (3 %) among children with mild to moderately severe bronchiolitis.MethodsInfants 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.ResultsA 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.ConclusionsNebulized 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 registrationClinicaltrials.gov NCTID012766821. Registered on January 12, 2011.
Highlights
To Assess the efficacy of nebulised hypertonic saline (HS) (3 %) among children with mild to moderately severe bronchiolitis
Primary outcome Compare the mean change in Clinical Severity score among patients with bronchiolitis treated with either L-Epinephrine- 3 % Hypertonic saline or L-Epinephrine0.9 % saline
We proposed that a difference of 1 point in the Clinical severity (CS) score between the two intervention groups will be considered clinically significant
Summary
Trial design This study was a prospective, interventional, doubleblind randomized controlled trial. Primary outcome Compare the mean change in Clinical Severity score among patients with bronchiolitis treated with either L-Epinephrine- 3 % Hypertonic saline or L-Epinephrine0.9 % saline. We proposed that a difference of 1 point in the CS score between the two intervention groups will be considered clinically significant. To detect this mean difference of 1 unit in the CS score, with a power of 95 %, a sample size of 44 in each intervention group was required This required a total of 88 patients to be enrolled in the study. Age (months), mean (SD); (range) Males, n(%) Duration of illness (days), Mean ± SD Mean (SD) respiratory rate (range) Mean (SD) heart rate (range) Mean (SD) Spo (range) Mean (SD) clinical severity score (range) Mean temperature (SD) temperature (*C) (range) Urine specific gravity ER enrollment, n (%). This trial has been reported in accordance to the Consolidated Standards of Reporting Trials (CONSORT, 2010) guidelines [29]
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