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. 2021 Feb 5;2021(2):CD011878. doi: 10.1002/14651858.CD011878.pub3

Babaei 2019.

Study characteristics
Methods Clinical trial conducted on all hospitalized neonates diagnosed with TTN in the neonatal intensive care unit (NICU) of Imam Reza Hospital in Kermanshah, Iran, during 2017
Participants 80 newborns (40 in the salbutamol group, 40 in the placebo group)
Inclusion criteria:

  1. gestational age of at least 35 weeks; and

  2. physical examination and radiologic findings suggesting TTN diagnosis.


Exclusion criteria:

  1. meconium aspiration;

  2. respiratory distress syndrome;

  3. congenital pneumonia;

  4. polycythemia;

  5. hypoglycemia;

  6. early onset sepsis;

  7. cardiac disorders;

  8. tachycardia (HR > 180 b/min);

  9. cardiac arrhythmia;

  10. congenital anomaly.
Interventions The treatment group received one dose of nebulized salbutamol (dose of 0.15 mL/kg in 2 mL of normal saline).
The placebo group received 2 mL 0.9% normal saline without salbutamol.
Outcomes

  1. Duration of tachypnea;

  2. Oxygen therapy;

  3. Mechanical ventilation;

  4. Continuous positive airway pressure support (CPAP);

  5. Hospital stay;

  6. Time of initiating enteral feeding.
Notes The study was also registered in the Iranian Clinical Trials (IRCT2017081414333N80code).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table
Allocation concealment (selection bias) Unclear risk No details available
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No information provided
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No information provided
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants accounted for
Selective reporting (reporting bias) Unclear risk The secondary outcomes were not reported in the protocol.
Other bias Low risk Appeared free of other bias