Mandelberg 2003.
Methods | Design: randomised, double‐blind, parallel‐group, controlled trial | |
Participants | Setting: paediatric inpatient ward, Edith Wolfson Medical Center, Israel
Eligible: not stated
Randomised: 27 (3% saline group); 26 (0.9% saline group)
Completed: 27 hypertonic saline group; 25 normal saline group
Gender (male): 57.7%
Age (mean ± SD): 2.9 ± 2.1 months (range 0.5 to 12 months) Inclusion criteria: infants with clinical presentation of viral bronchiolitis with temperature > 38 ºC that led to hospitalisation Exclusion criteria: cardiac disease, chronic respiratory disease, previous wheezing episode, age > 12 months, SaO₂ < 85% in room air, changes in consciousness and/or progressive respiratory failure requiring mechanical ventilation |
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Interventions | Intervention group: nebulised 3% saline solution (4 mL) plus 1.5 mg epinephrine Control group: nebulised 0.9% saline solution (4 mL) plus 1.5 mg epinephrine The treatment was given 3 times/day at intervals of 8 h, until the infant was ready for discharge. All inhaled treatments were delivered using a nebuliser (Aeromist Nebulizer Set 61400; B&F Medical by Allied; Toledo, OH) connected to a source of pressurised oxygen at a flow rate of 5 L/min. | |
Outcomes |
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Notes | RSV positive: 85% in hypertonic saline group; 88% in normal saline group | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details provided. |
Allocation concealment (selection bias) | Low risk | Study solutions were similar in colour, smell, and other physical properties. The code of the therapeutic package (hypertonic saline versus normal saline solution) was deposited with the statistician. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 (1.8%) withdrawal after randomisation |
Selective reporting (reporting bias) | Low risk | All predefined outcomes reported. |
Other bias | Low risk | No other bias found. |