OBJECTIVE: To demonstrate that heated humidified high-flow nasal cannula (HHHFNC) is superior to inhaled hypertonic saline solution (HSS) in improving respiratory distress in moderate bronchiolitis. In addition, it could improve comfort and reduce length of hospital stay (LOS) and admission to Paediatric Intensive Care Unit (PICU). DESIGN: Randomised Clinical Trial from 1 October 2010 to 31 December 2012. SETTING:Two urban secondary (no PICU available) paediatric hospitalisation units. PATIENTS: Hospitalised children aged up to 6 months with moderate acute bronchiolitis (Respiratory Distress Assessment Instrument, RDAI ≥4). INTERVENTION: Patients were randomised to HHHFNC or HSS. All of them received epinephrine as bronchodilator. MAIN OUTCOMES: Primary outcome was difference in mean Respiratory Assessment Change Score (RACS) between both groups measured in six previously defined consecutive moments. Secondary outcomes were difference in mean comfort scores in this period, LOS and rate of PICU admission. RESULTS:Seventy-five previously healthy patients were enrolled. Mean age was 2.4 months (95% CI 2.04 to 2.76). 43 were allocated to HSS group and 32 in HHHFNC. Data of 1 patient were lost, and 8 changed group over the study period. Intention-to-treat principle was applied. There were no significant differences in mean RACS and mean comfort scores between groups at the evaluation points. Median LOS or PICU admission rate were similar in both groups. No adverse events were observed. CONCLUSIONS:HHHFNC was not superior to HSS in treatment of moderate acute bronchiolitis with respect to severity and comfort scores, LOS or PICU admission rate. CLINICAL TRIAL REGISTRATION CLINICALTRIALSGOV IDENTIFIER: NCT01873144. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
OBJECTIVE: To demonstrate that heated humidified high-flow nasal cannula (HHHFNC) is superior to inhaled hypertonicsaline solution (HSS) in improving respiratory distress in moderate bronchiolitis. In addition, it could improve comfort and reduce length of hospital stay (LOS) and admission to Paediatric Intensive Care Unit (PICU). DESIGN: Randomised Clinical Trial from 1 October 2010 to 31 December 2012. SETTING: Two urban secondary (no PICU available) paediatric hospitalisation units. PATIENTS: Hospitalised children aged up to 6 months with moderate acute bronchiolitis (Respiratory Distress Assessment Instrument, RDAI ≥4). INTERVENTION: Patients were randomised to HHHFNC or HSS. All of them received epinephrine as bronchodilator. MAIN OUTCOMES: Primary outcome was difference in mean Respiratory Assessment Change Score (RACS) between both groups measured in six previously defined consecutive moments. Secondary outcomes were difference in mean comfort scores in this period, LOS and rate of PICU admission. RESULTS: Seventy-five previously healthy patients were enrolled. Mean age was 2.4 months (95% CI 2.04 to 2.76). 43 were allocated to HSS group and 32 in HHHFNC. Data of 1 patient were lost, and 8 changed group over the study period. Intention-to-treat principle was applied. There were no significant differences in mean RACS and mean comfort scores between groups at the evaluation points. Median LOS or PICU admission rate were similar in both groups. No adverse events were observed. CONCLUSIONS: HHHFNC was not superior to HSS in treatment of moderate acute bronchiolitis with respect to severity and comfort scores, LOS or PICU admission rate. CLINICAL TRIAL REGISTRATION CLINICALTRIALSGOV IDENTIFIER: NCT01873144. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Gloria S Pryhuber; Nathalie L Maitre; Roberta A Ballard; Denise Cifelli; Stephanie D Davis; Jonas H Ellenberg; James M Greenberg; James Kemp; Thomas J Mariani; Howard Panitch; Clement Ren; Pamela Shaw; Lynn M Taussig; Aaron Hamvas Journal: BMC Pediatr Date: 2015-04-10 Impact factor: 2.125