Points of action | Screening | Baseline | Visits | End of inpatient study | Follow-up | End of study | |||
---|---|---|---|---|---|---|---|---|---|
Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
Time point/age | Prior birth | 0 h | 120 h | Day 7 | PMA 36 | Discharge | 24 months corrected age | 60 months of age | |
Inclusion criteria | ● | ||||||||
Exclusion criteria | ● | ||||||||
Informed consent | ● | ||||||||
Neonatal and maternal characteristics | |||||||||
Data | ● | ||||||||
Study intervention/ventilation | |||||||||
Start | ● | ||||||||
End | ● | ||||||||
PEEP data | ● | ||||||||
Surfactant treatment | ● | ||||||||
Ventilation data | ● | ● | ● | ||||||
Safety | |||||||||
Serious adverse events | Continuous reporting until discharge | ||||||||
Outcome assessment | |||||||||
BPD | ● | ||||||||
Death | ● | ● | |||||||
ROP | ● | ||||||||
NEC | ● | ||||||||
FIP | ● | ||||||||
PDA | ● | ||||||||
Nosocomial infections | ● | ||||||||
Brain injury (CUS) | ● | ● | |||||||
Feeding data | ● | ||||||||
Inotropes | ● | ||||||||
Postnatal steroids | ● | ||||||||
Bayley III/GMFCS | ● | ||||||||
Visual and hearing | ● | ||||||||
Lung function | ● | ||||||||
WPPSI-III | ● | ||||||||
Lung/brain MRI | ● | ||||||||
Parental questionnaire | Every 3 months after discharge |