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. 2015 Sep 18;2015(9):CD006915. doi: 10.1002/14651858.CD006915.pub3

Hollmann 1998.

Methods Randomised, double‐blind, controlled, cross‐over study
Participants 13 infants (3 weeks to 23 months old) admitted to the PICU with RSV bronchiolitis RSV+, FiO2 < 50%,
 Criteria for inclusion:
 Bronchiolitis RSV+, with signs of lower respiratory tract disease
 Baseline characteristics, median (range):
 Age, mo 2.5 (3 wks to 24 mos)
 Clinical Asthma Score (m‐WCAS, maximum score of 10): 3.04 (1 to 7.5).
Interventions Inhalation in a random order of heliox AND air‐oxygen, by non‐rebreather standard reservoir mask for two 20‐minute study periods
Outcomes Primary endpoint: Clinical Asthma Score at 20 min
 Secondary endpoints: respiratory rate, heart rate and SpO2
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Coin tossing
Allocation concealment (selection bias) Low risk  
Blinding (performance bias and detection bias) 
 All outcomes Low risk 1 investigator was not blinded: the respiratory therapists; blinding was maintained by covering the on‐off valves to the air and helium sources with tape
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients completed the study and there were no losses to follow‐up, no treatment withdrawals
21 eligible patients were admitted during the study period. 3 patients were excluded from the study because of technical difficulties in setting up the gas delivery system (n = 1) and because of marked agitation (n = 2). 1 of the patients with agitation was intubated shortly after admission to the ICU. A total of 18 patients were studied, 13 of whom were randomised. Of the 13 randomised patients, 12 patients had Clinical Asthma Scores of < 6 and 1 patient had a Clinical Asthma Score of 7.5 but only mild signs of expiratory obstruction
Selective reporting (reporting bias) Low risk All results for outcomes were reported
Other bias Low risk