Topic and timing | Specific data elements |
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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 5Â days after treatment allocation | Extubation failure criteria: blood gas values, highest FiO2, number of apnea/bradycardia events over the previous 24Â h Intubation, including timing and indication All respiratory settings and FiO2 values |
Respiratory Status obtained weekly from treatment allocation until 36Â 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 36Â weeks PMA | Respiratory support mode and settings at 36Â weeks PMA Supplemental oxygen at 36Â weeks PMA |
Safety outcomes by 36Â 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 36Â weeks PMA | Brain injury, retinopathy of prematurity, sepsis, patent ductus arteriosus, pulmonary hemorrhage, necrotizing enterocolitis Any surgical procedures |