Dumas 2011.
Methods | This is a prospective, unmasked, randomized controlled clinical trial to assess efficacy of NHFPV compared to NCPAP. | |
Participants | 46 infants born by caesarian section ≥ 37 GA, ≥ 2000 g with diagnosis of TTN and with a transcutaneous saturation < 90% at 20 m after birth were eligible. 3 infants in each group were excluded before receiving the allocated intervention. | |
Interventions | Infants were randomized to either NHFPV or NCPAP. | |
Outcomes | The primary endpoint was the duration of respiratory distress. Secondary endpoints were the duration and level of oxygen supplementation, and the incidence of pneumothorax, and pulmonary infections. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Newborns were assigned using a table of random numbers. |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes were used. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The assigned intervention could not be blinded. |
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 (NCT00556738 ). |
Other bias | Low risk | Appears free of other bias. |