Variable/outcome | Type of outcome | Statistical analysis |
---|---|---|
Study phase I: short-term outcomes until initial hospital discharge | ||
BPD-free survival at 36 weeks PMA | Primary | Logistic regression with correction for stratification factors plus sensitivity and sub-group analyses |
Death at 28 days PNA, at 36 weeks PMA and at hospital discharge BPD at 36 weeks PMA Failure to extubate 3, 7, 14 and 21 days after start of trial medication Time to extubation, censored at death Time to supplemental oxygen independence Time to hospital discharge Necrotising enterocolitis Gastrointestinal bleeding Spontaneous intestinal perforation Intraventricular haemorrhage and/or periventricular leucomalacia Retinopathy of prematurity Hypertension Hyperglycaemia requiring insulin therapy Nosocomial infection, including clinical or culture-proven sepsis, meningitis, pneumonia Patent ductus arteriosus needing medical intervention or surgical ligation Weight, head circumference, length at 36 weeks PMA Use of open-label HC treatment | Short-term secondary | Linear, logistic or Cox regression or competing risk model, as appropriate |
SUSARs, SAEs | Short-term secondary | Descriptive statistics |
Study phase II: long-term follow-up at 2 years CA | ||
Survival without neurodevelopmental impairment | Key long-term secondary | Logistic regression with correction for stratification factors, sensitivity and sub-group analyses |
Mortality Number of hospital readmissions since first discharge to home Cerebral palsy and its severity Hearing loss requiring hearing aids Blindness Behaviour problems (Child Behavior Checklist)Growth (weight, length, head circumference) | Long-term secondary | Linear, logistic or Cox regression or competing risk model, as appropriate |