Schwaberger 2015

Methods	Prospective randomised parallel controlled trial Setting: Delivery Room, Graz, Austria Conducted: April 2012 to December 2013
Participants	Inclusion criteria: preterm infants (28 weeks 0 days to 33 weeks 6 days) delivered by elective Caesarean section with HR < 100 or irregular breathing and/or pronounced signs of respiratory distress (grunting, tachypnoea, and increased work of breathing) Exclusion criteria: major congenital malformations, inherited disorders of metabolism and necessity of primary intubation within first 15 minutes after birth. In cases of multiple birth, only 1 of the infants was included
Interventions	Cord clamping within 30 seconds after delivery. Respiratory support with a T‐piece system in the delivery room SLI group: PIP 30 cmH2O for 15 seconds, with mask, to be repeated once or twice with HR remaining below 100 bpm. Infants with HR > 100 bpm were supported by PPV at 30 cmH2O PIP or CPAP at a PEEP level of 5 cmH2O depending on respiratory rate Control group: Respiratory support was provided according to AHA guidelines. CPAP (5 cmH2O PEEP) was applied in infants with respiratory rate > 30 breaths per minute and signs of respiratory distress. Insufficient breathing efforts (HR < 100 bpm, respiratory rate < 30 breaths per minute or irregular breathing) indicated PPV at 30 cmH2O PIP via face mask Initial fraction of inspired oxygen (FiO2) of 0.3 was adapted to achieve defined oxygen saturation targets (3‘: > 60%; 5‘: > 75%; 10‘: > 85%)
Outcomes	Primary outcome: changes in cerebral blood volume and cerebral tissue oxygenation index during immediate postnatal transition Secondary outcomes: SpO2, HR, VT, face mask leak, FiO2 within first 15 minutes after birth
Notes	Trial was registered at the German Clinical Trials Register (DRKS00005161) in July 2013, after study initiation (April 2012)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated blocked randomisation, 1:1 ratio, with a block size of 8 (www.randomizer.at)
Allocation concealment (selection bias)	Low risk	Sealed envelopes were used. We obtained the following information directly from trial authors: Envelopes were opaque
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	Cerebral ultrasound pictures were evaluated by a neonatologist blinded to participants. No information was provided for the other outcomes
Incomplete outcome data (attrition bias) All outcomes	Low risk	All outcomes accounted for
Selective reporting (reporting bias)	Low risk	Protocol for this trial is available as supporting information. Reporting of the study conforms to Consolidated Standards of Reporting Trials (CONSORT) 2010 statement
Other bias	Low risk	Appears free of other bias.

AAP: American Academy of Pediatrics AHA: American Heart Association BPD: bronchopulmonary dysplasia C:V: compression:ventilation CBMI: conventional bag/mask inflation CPAP: continuous positive airway pressure DR: delivery room ECO2: enzymatic carbonate (measure of carbon dioxide in the blood) FiO2: fraction of inspired oxygen HR: heart rate IL‐1b: interleukin‐1beta IMV: intermittent mandatory ventilation IPPV: intermittent positive pressure ventilation IVH: intraventricular haemorrhage MV: mandatory ventilation NCPAP: nasal continuous positive airway pressure NEC: necrotising enterocolitis NICU: neonatal intensive care unit NIMV: nasal intermittent mandatory ventilation PDA: patent ductus arteriosus PEEP: positive end‐expiratory pressure PIP: peak inspiratory pressure PPV: positive pressure ventilation RDS: respiratory distress syndrome ROP: retinopathy of prematurity SLI: sustained lung inflation SpO2: blood oxygen saturation level TNF‐a: tumour necrosis factor‐alpha VT: ventricular tachycardia