Adverse event reporting and harms {22}
NEC, ROP, pneumothorax, IVH, deaths, FIP, PVL
ADVERSE REACTIONS, PRETERM BIRTH, INTRAVENTRICULAR HAEMORRHAGE, NECROTISING ENTEROCOLITIS, PNEUMOTHORAX, ADVERSE EVENTS, FIP, COMPLICATIONS
Preterm infants are a vulnerable group of patients and a high number of adverse events was anticipated in the pro.LISA trial. Typical complications of preterm birth (e.g. intraventricular haemorrhage, surgery due to necrotising enterocolitis) were defined as adverse events, are collected systematically, and are entered in the pro.LISA online database. Serious adverse events (deaths in particular) are reported to the principal investigator within 24 h either by fax or in the pro.LISA online database. Unexpected harms will be also collected as adverse events or serious adverse events in the online database. Harms will not be classified according to standardised classifications like the “common terminology criteria for adverse events”. Suspected unexpected serious adverse reactions are not expected since more than a million preterm infants have already been treated with surfactant. Suspected unexpected serious adverse reactions will be reported to the principal investigator within 24 h.Descriptive analyses of adverse events and serious adverse events including IVH, PVL, surgery for PDA, surgery for NEC, surgery for FIP, surgery for ROP, and pneumothorax are provided every month to the data and safety monitoring board and participating sites.