Mercadante 2016.
Methods | Prospective randomised parallel controlled trial Setting: Delivery Room, NICU in Milan, Italy Conducted: September 2013 to June 2014 |
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Participants | Inclusion criteria: inborn infants with a gestational age of 34 to 36 weeks after parental consent is obtained Exclusion criteria: major congenital anomalies |
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Interventions |
In both groups, mask and T‐piece system were used |
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Outcomes | Primary outcome: rate of respiratory support Secondary outcomes: air leak syndromes, NICU admission, NICU admission for respiratory disease, length of stay, exclusive breastfeeding at discharge |
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Notes | Sample size described | |
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 | Sealed opaque envelopes |
Blinding (performance bias and detection bias) All outcomes | High risk | Assigned intervention could not be blinded to the resuscitation team |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The decision to start respiratory support was made by clinicians other than investigators involved in the study according to specific guidelines, and researchers assessing study endpoints were blinded to the nature of study treatments |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes accounted for |
Selective reporting (reporting bias) | High risk | We could not ascertain whether deviations from the original protocol were evident in the final publication |
Other bias | Low risk |