Table 5 Key data to be collected for enrolled subjects

Pre-randomization characteristics

Demographics: birth weight, gestational age at birth, sex, race, ethnicity, multiple gestations, small for gestational age at birth, postnatal age at randomization

Maternal characteristics: antenatal steroids, clinical diagnosis of chorioamnionitis, diagnosis of PPROM, mode of delivery

Postnatal interventions: surfactant (number, timing, and method of administration), postnatal steroids

Respiratory interventions: duration of mechanical ventilation, mode of ventilation and highest settings, ventilator settings at the time of extubation, postnatal age (days) at extubation, interval (hours) between extubation and initiation of allocated ventilator mode

Daily respiratory status, obtained daily for the first 5 days after treatment allocation

Extubation failure criteria: blood gas values, highest FiO₂, number of apnea/bradycardia events over the previous 24 h

Intubation, including timing and indication

All respiratory settings and FiO₂ values

Respiratory Status obtained weekly from treatment allocation until 36 weeks PMA

Timing and indication for all intubations

Timing of extubation

Start/stop dates of modes of support (i.e., invasive ventilation, non-invasive ventilation, CPAP, cannula, room air)

Respiratory medications, including diuretics and postnatal steroids

PMA at last invasive ventilation, positive pressure, and supplemental oxygen

Respiratory status at 36 weeks PMA

Respiratory support mode and settings at 36 weeks PMA

Supplemental oxygen at 36 weeks PMA

Safety outcomes by 36 weeks PMA

Air leaks, GI perforation and bleeding, and death (date and primary cause of death; narrative autopsy results if performed)

Secondary clinical outcomes by 36 weeks PMA

Brain injury, retinopathy of prematurity, sepsis, patent ductus arteriosus, pulmonary hemorrhage, necrotizing enterocolitis

Any surgical procedures