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. 2020 Mar 17;2020(3):CD013222. doi: 10.1002/14651858.CD013222.pub2

Vaisbourd 2017.

Methods Double‐blind, randomised, placebo‐controlled, multicentre pilot study.
Setting: most of the participants (approximately 75%) were recruited in Bnai Zion Medical Center, Technion, Haifa, Israel.
Conducted: March 2012 to June 2016
Participants Late preterm and term infants (number of participants (n) = 49) born at ≥ 34 weeks' gestational age with transient tachypnoea of the newborn (TTN), defined as:
  1. onset of tachypnoea within 6 hours after birth and need for oxygen > 25%;

  2. tachypnoea persisting for at least 4 hours;

  3. chest radiograph indicating at least one of the following: prominent central vascular markings, widened interlobar fissures with pleural fluid, symmetrical perihilar congestion;

  4. the symptoms and radiographic findings were transient and self‐limited, disappearing within the first week of life.


Exclusion criteria: infants with either meconium aspiration syndrome, respiratory distress syndrome, or congenital heart disease, non‐respiratory disorders causing tachypnoea, pneumonia by chest x‐ray, suspected sepsis/bacteraemia, or exposed to prenatal steroids.
Interventions
  • Inhaled corticosteroids: 1000 microgram budesonide (2  mL; n = 24)

  • Placebo: 0.9% normal saline solution (2 mL; n = 25)


Inhalations were performed with a face mask when the infants were held in a semi‐seated position with the neck slightly extended in the crib or incubator. The mask was held firmly against the infant's face.
Outcomes Primary outcome: TTN clinical score
Secondary outcomes: time to spontaneous unsupported breathing of room air, time to spontaneous breathing for infants who received a higher level of respiratory support, maximal level of respiratory support, length of stay, time to full feeds, need and length of antibiotic therapy
Notes This was a pilot study (sample size was calculated)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided.
Allocation concealment (selection bias) Low risk Coded covered syringes were used to conceal the allocation.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The code allocation was known only to the pharmacy in each centre. The codes were opened only at the end of the study.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk See above.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All reported outcomes were provided with complete results.
Selective reporting (reporting bias) Low risk Registered clinical trial outcomes are reported.
Other bias Low risk The trial appeared free of other bias.