Skip to main content
. 2017 Dec 21;2017(12):CD006458. doi: 10.1002/14651858.CD006458.pub4

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
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
  • Length of hospital stay

  • Wang clinical severity score

  • Oxygen saturation

  • Pulse rate

  • Radiograph assessment score

  • Number of add‐on treatments

  • Adverse events

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.