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. 2020 Mar 18;2020(3):CD004953. doi: 10.1002/14651858.CD004953.pub4

Mercadante 2016.

Methods Prospective randomised parallel controlled trial
Setting: Delivery Room, NICU in Milan, Italy
Conducted: September 2013 to June 2014
Participants Inclusion criteria: inborn infants with a gestational age of 34 to 36 weeks after parental consent is obtained
Exclusion criteria: major congenital anomalies
Interventions
  • SLI group: PIP 25 cmH₂O for 15 seconds in the delivery room, followed by PEEP of 5 cmH₂O. In case of persistent heart failure (HR < 100 bpm), a second SLI manoeuvre will be repeated

  • Control group: CPAP 5 cmH₂O with mask


In both groups, mask and T‐piece system were used
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
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