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. 2017 Dec 21;2017(12):CD006458. doi: 10.1002/14651858.CD006458.pub4

Ipek 2011.

Methods Design: quasi‐randomised, double‐blind, parallel‐group, controlled trial
Participants Setting: paediatric emergency department of a training and research hospital in Turkey
 Eligible: not stated
 Randomised: 60 hypertonic saline group; 60 normal saline group
 Completed: 60 hypertonic saline group; 60 normal saline group
 Gender (male): 59.2%
 Age (mean ± SD): 7.9 ± 3.9 months
Inclusion criteria: age < 2 years, a history of preceding viral upper respiratory infection followed by wheezing and crackles on auscultation, and a clinical severity score of 4 to 8 on admission
Exclusion criteria: infants with clinical severity score < 4 or > 8, SaO₂ < 85% on room air, chronic cardiac illness, premature birth, birth weight < 2500 g, history of recurrent wheezing episodes, proven immune deficiency, severe neurological disease, age < 1 month or > 2 years, consolidation or atelectasis on a chest roentgenogram
Interventions Intervention groups:
 Group 1: nebulised 3% hypertonic saline (4 mL) plus salbutamol 0.15 mg/kg
 Group 2: nebulised 3% hypertonic saline (4 mL) alone
Control groups:
 Group 1: nebulised 0.9% hypertonic saline (4 mL) plus salbutamol 0.15 mg/kg
 Group 2: nebulised 0.9% hypertonic saline (4 mL) alone
The treatment was given every 20 min until 3 doses had been administered (0, 20, and 40 min). All inhaled therapies were delivered via a compressor nebuliser through a face mask with continued flow of oxygen at 4 to 5 L/min (Mini Compressor Nebulizer, CN‐02WD, Ace‐Tec Co., Ltd., Guangdong, China).
Outcomes

  • Wang clinical severity score

  • Oxygen saturation

  • Respiratory rate

  • Heart rate

  • Corticosteroid need

  • Rate of hospitalisation

  • Adverse events
Notes Virological identification not available.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Infants were assigned to 1 of 4 groups according to the consecutive order of their admission to the short‐stay unit.
Allocation concealment (selection bias) High risk As stated above
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk The trial was stated to be double‐blind, but no details were provided.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No withdrawals reported.
Selective reporting (reporting bias) Low risk All predefined outcomes reported.
Other bias Low risk No other bias found.