REspiratory MEchanics for Delivering Individualised Exogenous Surfactant

First surfactant administration

Time of first surfactant administration (in hours)

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Days of non-invasive respiratory support

Number of days of non-invasive respiratory support

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Days of invasive respiratory support

Number of days of invasive respiratory support

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Patients intubated and mechanically ventilated

Number of patients intubated and mechanically ventilated

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Patients receiving multiple surfactant doses

Number of patients receiving multiple surfactant doses

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Days on supplemental oxygen

Number of days on supplemental oxygen

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Total cumulative oxygen exposure

Total cumulative oxygen exposure computed as the time integral of the FiO2 values

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Infants receiving more than 28 days of respiratory support

Number of infants receiving more than 28 days of respiratory support

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Infants developing BPD

Number of infants developing BPD according to the definition by NICHD 2016

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Infants developing air-leaks

Number of infants developing air-leaks

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Infants developing prematurity-associated complications

Number of infants developing prematurity-associated complications (severe intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC), sepsis, retinopathy of prematurity (ROP), patent ductus arteriosus requiring pharmacological or surgical treatment)

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Infants discharged home with oxygen or respiratory support

Number of infants discharged home with oxygen or respiratory support

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Days to achieve full-enteral feeding

Number of days to achieve full-enteral feeding (160 ml/kg/day of milk intake)

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Days of hospitalization

Number of days of hospitalization

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Infants receiving postnatal steroids

Number of infants receiving postnatal steroids

Time frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"