BACKGROUND. Sustained lung inflation (SLI) associated to an adequate PEEP may help the
efficacy of the respiratory effort in lung of preterm infants at risk for respiratory
distress syndrome (RDS) and reduce need of mechanical ventilation (MV).
The investigators aim will be to demonstrate the hypothesis that the introduction of SLI in
the delivery room protocol may reduce the need of MV in preterm infants.
STUDY DESIGN: Multicenter prospective randomized controlled trial. The study will be carried
out at the neonatal care units of the Careggi Infants with a gestational age between 25 and
28 weeks will be eligible and randomized at birth to receive SLI or not. Peak inflation
pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a positive
end expiratory pressure (PEEP) of 5 cm H2O.
Primary endpoint will be the need of MV within the first 72 hrs of life (excluding the
transient tracheal intubation for surfactant replacement: e.g. INSURE). Population size:
hypothesizing that SLI maneuver might decrease the need of MV during the first 72 hours of
life from 35 to 20% the investigators calculated that 138 newborns must be enrolled in each
groups to detect this difference statistically significant with 80% power at 0.05 level.