Variable | Definition |
---|---|
Patient-level information on characteristics at enrolment | |
Complete course of antenatal corticosteroids | A course of at least 2 doses started > 48 hours before delivery or completed > 24 hours before delivery |
Antenatal corticosteroids, any treatment | Any antenatal treatment with corticosteroids, regardless of the interval with delivery |
Chorioamnionitis | As defined in the trial |
Oxygenation index (OI) | OI = MAP × FiO2 × 100/P aO2 With |
MAP = mean airway pressure | |
FiO2 = fractional inspired oxygen | |
P aO2 = partial arterial oxygen tension | |
Patient-level information on trial intervention and co-interventions | |
MAP at stabilization | Mean airway pressure in the first 24 hours after randomization. |
FiO2 at stabilization | Fractional inspired oxygen in the first 24 hours after randomization. |
Postnatal corticosteroids | Postnatal treatment with corticosteroids for the prevention or treatment of bronchopulmonary dysplasia |
Early administration of cyclo-oxygenase inhibitor | Administration of indomethacin or ibuprofen in the first 24 hours of life in order to prevent patent ductus arteriosus or intracranial haemorrhage |
Neonatal outcomes | |
Death | Death before discharge from neonatal intensive care unit (NICU) |
BPD at 36 weeks PMA | Oxygen therapy at the postmenstrual age of 36 weeks |
Severe adverse neurological event | Intracranial haemorrhage grade 3 or 4, and/or cystic periventricular leukomalacia |
Gross pulmonary air leak | Pneumothorax and/or pneumomediastinum and/or pneumopericardium |
PDA requiring treatment | Patent ductus arteriosus requiring treatment with non-steroidal anti-inflammatory drugs or surgery |
Any pulmonary air leak | Gross pulmonary air leak and/or pulmonary interstitial emphysema (PIE) |
Neurological disability | Motor and/or cognitive and/or auditory and/or visual impairment |