Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes

Table 3 Trial assessments

Procedure	Baby hospitalisation
Procedure	Screening^a	Trial entry and treatment (days 1−3)	Up to 7 days after trial medication	3 weeks of age	36 weeks of PMA	Discharge
Demography^g		✓				✓
Echocardiogram/colour Doppler^f	✓			✓
Confirmation of eligibility	✓
Consent		✓
Randomisation^b		✓
Ibuprofen/placebo dosing^c		✓
IVH/PVL ultrasound scans^h			✓		✓
NEC						✓
Oxygen reduction test					✓
SAEs^d		✓	✓
Concomitant medication^e	✓	✓		✓	✓	✓

^aScreening assessments to be completed sufficiently in advance to enable randomisation and dosing within 72 h of birth. If consent cannot be obtained before echocardiographic evaluation for eligibility, echocardiographic assessment should continue, and consent obtained when possible if a baby is deemed eligible
^bRandomisation to be completed sufficiently in advance to enable dosing within 72 h of birth
^cInitial trial drug administrations to be given soon after randomisation, after 6 h of age and within 72 h of birth. Subsequent doses to be administered 24 h after the initial dose
^dOnly adverse events which are serious will be recorded from first dose until 7 days after trial medication. Only unforeseeable SAEs will be reported
^eConcomitant medications to be recorded only in relation to unforeseeable SAEs. In the event of an unforeseeable SAE all concomitant medication, including medication given to the baby’s mother, 7 days prior to the onset of the event to the time of its resolution must be recorded on the SAE form
^fAn echocardiogram scan will be performed when the baby reaches around 3 weeks of age (range of 18–24 days) or at hospital discharge if discharged earlier
^gDemography and medications will be assessed through the PARCA-R and other questionnaires
^hIf a baby transfers from the recruiting site to a continuing care site for on-going care details of any scan would be helpful

ISSN: 1745-6215