Outcomes {12}
bleeding, IVH, dysplasia, ductus arteriosus, DeathIntraventricular haemorrhage, BPD, intestinal perforation
BLEEDING, NECROTISING ENTEROCOLITIS, PERIVENTRICULAR LEUKOMALACIA, DYSPLASIA, OBSTRUCTIVE BRONCHITIS, CEREBRAL PALSY, INTESTINAL PERFORATION, RETINOPATHY OF PREMATURITY
The primary endpoint of this study is FEVFVC FEVLength in metres of running track in 3-min running test according to [Cerebral palsy defined as Gross Motor Function Classification System value > 1Score in Movement Assessment Battery for ChildrenIntelligence assessed by Wechsler Preschool and Primary Scale of Intelligence (WPPSI) IVObstructive bronchitis (treated with inhaled or other drugs) in the last 12 monthsSpirometry measures (FEVThe following safety endpoints will be assessed at discharge from the hospital:DeathIntraventricular haemorrhage (IVH, each grade)IVH grade III or IVPeriventricular leukomalacia (PVL)Abdominal operation due to focal intestinal perforation (FIP)Abdominal operation due to necrotising enterocolitis (NEC)Laser surgery, cryocoagulation, or anti-VEGF treatment of retinopathy of prematurity (ROP)Operation due to a persistent ductus arteriosus (PDA)PneumothoraxBronchopulmonary dysplasia (BPD, need of ODeath or BPDDuration of mechanical ventilation (in days)Duration for need of ODuration of need of any breathing assistance (ventilation or CPAP) (in days)Mechanical ventilation during stay in hospitalMechanical ventilation during the first 72 h of lifeHerniotomyAbdominal operation due to other reasonsLung bleeding where transfusion or intubation is requiredBody weightBody lengthOne of the endpoints in 1–10.The following safety endpoints will be assessed at the age of 5 years:General healthDevelopment compared to children of the same ageSystolic blood pressure (1st measurement)Systolic blood pressure (2nd measurement)Medium blood pressure (1st measurement)Medium blood pressure (2nd measurement)Diastolic blood pressure (1st measurement)Diastolic blood pressure (2nd measurement)Heart rateBreathing rateSpOSystolic blood pressure after running testDiastolic blood pressure after running testMedium arterial pressure (MAD) after running testHeart rate after running testBreathing rate after running testSpOSafety endpoints will be compared in the safety analysis dataset. The method of aggregation for safety endpoints until discharge will be proportions for numbers 1–11, 15–19, and 22 and median values for 12–14 and 20–21. The method for aggregation of data at 5-year follow-up will be proportions for items 1–2 and mean values for all other endpoints. All statistical analyses are described in detail in the statistical analysis plan, which will be finalised before the randomisation of the last patient in the study.