NCT01440868.

Trial name or title	Sustained lung inflation in the delivery room in preterm infants at high risk of respiratory distress syndrome. A RCT study
Methods	Multicentre prospective randomised controlled trial
Participants	Preterm infants of 25 to 28 weeks of gestational age Exclusion criteria: fetal hydrops, major congenital malformation, inherited metabolic diseases
Interventions	SLI group: in this group the preterm infants will receive SLI with mask in the delivery room SLI will be performed with mask using a pressure control system (Neopuff, Fisher & Paykel, Inc). PIP of 25 cmH₂O will be delivered for 15 seconds and then reduced to a PEEP of 5 cmH₂O. A second SLI manoeuvre will be repeated in case of persistent hearth failure (HR < 100 bpm ) Control group: preterm infants will be assisted in the delivery room without sustained lung inflation
Outcomes	Primary outcome: rate of mechanical ventilation(MV) within the first 72 hrs of life Secondary outcome: occurrence of MV > 3 hrs of life, length of MV and other non‐invasive respiratory supports, rate of surfactant, mortality, the occurrence of the main prematurity complication such as BPD, IVH , PVL, ROP and NEC, sepsis, and length of NICU and hospital stay.
Starting date	October 2011
Contact information	Carlo Dani, MD University of Florence, Italy
Notes	Original estimated enrolment: 276 Estimated primary completion date: September 2012