High flow therapy versus hypertonic saline in bronchiolitis: randomised controlled trial

MB Campaña, JO Ortiz, CN Muñoz… - Archives of disease in …, 2014 - adc.bmj.com
MB Campaña, JO Ortiz, CN Muñoz, MR Lucas, AF Rincón, OP Hernández, CC Rey
Archives of disease in childhood, 2014adc.bmj.com
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 …
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 ClinicalTrials.gov Identifier
NCT01873144.
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