Table 3.

Trial assessments

Procedure	Baby hospitalisation
	Screeninga	Trial entry and treatment (days 1−3)	Up to 7 days after trial medication	3 weeks of age	36 weeks of PMA	Discharge
Demographyg		✓				✓
Echocardiogram/colour Dopplerf	✓			✓
Confirmation of eligibility	✓
Consent		✓
Randomisationb		✓
Ibuprofen/placebo dosingc		✓
IVH/PVL ultrasound scansh			✓		✓
NEC						✓
Oxygen reduction test					✓
SAEsd		✓	✓
Concomitant medicatione	✓	✓		✓	✓	✓

^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