Lindner 2005.

Methods	Prospective randomised parallel controlled trial Setting: Delivery Room, Ulm, Germany Conducted: August 1999 to February 2002
Participants	Inclusion criteria: newly born infants at 25 to 28 weeks of gestation inclusive Exclusion criteria: severe malformations, oligohydramnios before 20 weeks of gestation, foeto‐foetal transfusion syndrome A total of 61 infants were enrolled (31 in sustained inflation group and 30 in control group)
Interventions	SLI group: PIP 20 cmH₂O for 15 seconds. Infants who did not respond satisfactorily (persistent poor or laboured respiratory effort, bradycardia or cyanosis, and low oxygen saturation (SpO₂)): up to 2 additional inflations of 15 seconds at higher inflating pressures (25 and 30 cmH₂O). Infants whose response remained unsatisfactory were intubated and mechanically ventilated Control group: NIMV (PIP 20 cmH₂O, PEEP 4 to 6 cmH₂O; inflation time 0.5 seconds; inflation rate 60/min) for 30 seconds before the start of NCPAP at 4 to 6 cmH₂O Infants received support from a mechanical ventilator via a nasopharyngeal tube Infants in both groups who had apnoea on NCPAP could be treated with NIMV (PIP 20 cmH₂O; inflation time 0.3 seconds; inflation rate 60/min) for up to 4 minutes Treatment was deemed to have failed if infants had shown persistently poor respiratory effort, bradycardia, or cyanosis/low SpO₂ in the delivery room; or if criteria combining clinical assessments of respiratory distress and evidence of impaired oxygenation, impaired ventilation (high CO₂), or apnoea were met within 48 hours of birth
Outcomes	Primary outcome: rate of infants reaching criteria for intubation and mechanical ventilation at < 48 hours of life Secondary outcomes: mortality, Apgar score, endotracheal intubation, surfactant administration, duration of respiratory support, chronic lung disease, air leak, intraventricular haemorrhage, cystic periventricular leukomalacia, retinopathy of prematurity, PDA
Notes	Trial was stopped before target sample was recruited owing to slow enrolment. Clinical outcomes were reported for all randomised infants
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Block randomised, stratified for gestational age (25 to 26 weeks, 27 to 28 weeks)
Allocation concealment (selection bias)	Low risk	Sealed opaque envelopes used
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	Low risk	All infants accounted for
Selective reporting (reporting bias)	Low risk	All reported outcomes provided with complete results
Other bias	Unclear risk	Trial lacks power because only 61 infants were enrolled (instead of 110)