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 |
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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:
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. |
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Interventions |
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. |
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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 |
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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. |