Demirel 2013.
Methods | This is a randomized‐prospective study, to evaluate the efficacy of NIMV in reducing the duration of respiratory distress compared with NCPAP in transient TTN. | |
Participants | 40 infants with a gestational age ≥ 37 weeks and birth weight ≥ 2000 g with TTN | |
Interventions | Patients were randomized to NIMV or NCPAP | |
Outcomes | The primary end point was the duration of respiratory distress. Secondary end points were the duration and level of oxygen supplementation, the incidence of complications such as pneumothorax, pneumonia and respiratory failure requiring intubation. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was performed by using sequential numbers generated at the computer center of the NICU. |
Allocation concealment (selection bias) | Low risk | The allocations were contained in opaque, sequentially numbered sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The assigned intervention could not be blinded to the team. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes accounted for. |
Selective reporting (reporting bias) | Low risk | The protocol was registered in ClinicalTrials.gov (NCT01499238). |
Other bias | Low risk | Appears free of other bias. |