NCT03518762.
Trial name or title | Sustained lung inflation in preterm infants |
Methods | Prospective randomised parallel controlled trial |
Participants | Preterm infants of 27 weeks 0 days and 32 weeks 6 days; appropriate for gestational age; weight > 800 grams |
Interventions | SLI group: PIP 20 cmH₂O for 15 seconds, using a T‐piece resuscitator, Neopuff device Control group: CPAP with mask, pressure 5 cmH₂O, using a T‐piece resuscitator, Neopuff device |
Outcomes | Primary outcome: rate of invasive mechanical ventilation at 72 hours of life Secondary outcomes: duration of invasive mechanical ventilation; duration of intubation and invasive mechanical ventilation; pneumothorax; BPD |
Starting date | December 2014 |
Contact information | Douaa El Saied El Sherbiny, Doctor, Kasr El Aini Hospital |
Notes | Estimated enrolment: 160 Estimated primary completion date: April 2017 |
BPD: bronchopulmonary dysplasia CC: chest compression CPAP: continuous positive airway pressure C:V: compression: ventilation DR: delivery room FiO₂: fraction of inspired oxygen IVH: intraventricular haemorrhage NEC: necrotising enterocolitis NICU: neonatal intensive care unit PDA: patent ductus arteriosus PEEP: positive end‐expiratory pressure PIE: pulmonary interstitial emphysema PIP: peak inspiratory pressure PPV: positive pressure ventilation PVL: periventricular leukomalacia RDS: respiratory distress syndrome ROP: retinopathy of prematurity SI: sustained inflation SLI: sustained lung inflation TNN: transient tachypnoea of the newborn