OBJECTIVES: Our study was aimed to evaluate the efficacy of 7% hypertonic saline and 0.1% hyaluronic acid (7% HS-HA) given by inhalation, in infants hospitalized for mild-to-moderate bronchiolitis. METHODS: In a double-blind controlled study, 39 infants (23 boys) <7 months of age (median age 2 months) were enrolled and randomly assigned to receive either nebulized 7% HS-HA (7%NaCl + 0.1%HA) (n:21) or 0.9 normal saline (NS) (n:18) at a dose of 2.5 ml twice a day for 3 days. All infants were assigned a clinical severity score at admission and four times daily during hospitalization. Main outcome measures were number of days hospitalization, safety and daily reduction in the severity score. RESULTS: No difference was found between the two groups for clinical severity score at admission. One child in the study group and two in the NS group interrupted the study protocol; 19% of infants in the study group and 11% in the NS group had mild cough after the aerosol. The length of stay in the control group and treatment groups were 4.8 ± 1.5 versus 4.1 ± 1.9 days, respectively (P = 0.09). There was a trend for shortening the hospitalization days in the treatment group by 14.6%. The use of NS in the control group was identified as an independent risk factor for length of hospital stay using the multivariate logistic regression model (P = 0.04). No difference was observed between the two groups for the clinical score reduction during the first 3 days hospitalization. CONCLUSIONS: 7% HS-HA is a safe and effective therapy in treating infants hospitalized for mild-to-moderate bronchiolitis.
RCT Entities:
OBJECTIVES: Our study was aimed to evaluate the efficacy of 7% hypertonic saline and 0.1% hyaluronic acid (7% HS-HA) given by inhalation, in infants hospitalized for mild-to-moderate bronchiolitis. METHODS: In a double-blind controlled study, 39 infants (23 boys) <7 months of age (median age 2 months) were enrolled and randomly assigned to receive either nebulized 7% HS-HA (7%NaCl + 0.1%HA) (n:21) or 0.9 normal saline (NS) (n:18) at a dose of 2.5 ml twice a day for 3 days. All infants were assigned a clinical severity score at admission and four times daily during hospitalization. Main outcome measures were number of days hospitalization, safety and daily reduction in the severity score. RESULTS: No difference was found between the two groups for clinical severity score at admission. One child in the study group and two in the NS group interrupted the study protocol; 19% of infants in the study group and 11% in the NS group had mild cough after the aerosol. The length of stay in the control group and treatment groups were 4.8 ± 1.5 versus 4.1 ± 1.9 days, respectively (P = 0.09). There was a trend for shortening the hospitalization days in the treatment group by 14.6%. The use of NS in the control group was identified as an independent risk factor for length of hospital stay using the multivariate logistic regression model (P = 0.04). No difference was observed between the two groups for the clinical score reduction during the first 3 days hospitalization. CONCLUSIONS: 7% HS-HA is a safe and effective therapy in treating infants hospitalized for mild-to-moderate bronchiolitis.
Authors: Christopher Kuehl; Ti Zhang; Lisa M Kaminskas; Christopher J H Porter; Neal M Davies; Laird Forrest; Cory Berkland Journal: Mol Pharm Date: 2016-05-24 Impact factor: 4.939