El‐Chimi 2017

Methods	Prospective quasi‐randomised parallel controlled trial Setting: delivery room of Maternity Hospital, Ain Shams University, Cairo, Egypt Conducted: April 2012 to March 2014
Participants	Inclusion criteria (as specified in the protocol): gestational age 26 to 33 weeks, birth weight > 750 grams Exclusion criteria (as specified in the protocol): major congenital anomalies; meconium aspiration syndrome, congenital diaphragmatic hernia, anterior abdominal wall defect, maternal chorioamnionitis
Interventions	SLI group: PIP of 20 cmH2O for 15 seconds, using a neonatal mask and a T‐piece ventilator, followed by PEEP of 5 cmH2O. If response was not satisfactory (i.e. breathing remained insufficient and/or heart rate was < 100 bpm and/or the infant was cyanotic): A second 15 second SLI of 25 cmH2O for 15 seconds, followed by PEEP of 6 cmH2O. If still not satisfactory, a third SLI of 30 cmH2O for 15 seconds, followed by PEEP of 7 cmH2O. If still not satisfactory, intubation inside DR and ventilation (rate of 40 to 60 breaths/min, PIP of 25 to 35 cmH2O, PEEP of 7 to 8 cmH2O) until transfer to NICU Control group: intermittent bag/mask inflation: rate of 40 to 60 breaths/min, maximum PIP of 40 cmH2O for 30 seconds using a self‐inflating bag with an oxygen reservoir. After adequate circulation and breathing achieved, CPAP of 5 to 7 cmH2O during transfer to NICU. In cases of poor response, intubation and ventilation (rate of 40 to 60 breaths/min, PIP of 25 to 35 cmH2O, PEEP of 7 to 8 cmH2O) until transfer to NICU
Outcomes	Primary outcome was either "success" (defined as no need for further ventilatory support, need for exclusive NCPAP, or need for intubation beyond the first 72 hours after delivery) or "failure" (defined as need for intubation within first 72 hours of life, including DR intubation) Secondary outcomes were blood IL‐1b and TNF‐a levels, air leaks, BPD, IVH, PDA, and NEC
Notes	Study was registered at ClinicalTrials.gov (Identifier: NCT01255826)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	For randomisation, sequentially numbered sheets were used to assign eligible infants to resuscitation: Odd‐numbered sheets indicated those allocated to the SLI group, and even‐numbered to the control group
Allocation concealment (selection bias)	High risk	No opaque envelopes were used (information provided by study authors)
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	Unclear risk	No information provided
Incomplete outcome data (attrition bias) All outcomes	High risk	After enrolment (n = 202), infants referred to other NICUs were excluded from analysis owing to failure of follow‐up. At study end, SLI group comprised 57 babies and CBMI group comprised 55 babies
Selective reporting (reporting bias)	High risk	Some outcomes were specified at https://clinicaltrials.gov/ct2/show/NCT01255826 but were not reported in the manuscript (e.g. duration of oxygen therapy, length of NICU stay)
Other bias	Low risk	Appears free of other bias