Infant at 2 Years Corrected Age6,7
Demography9	X
Visual Assessment6	X
Hearing Assessment6	X
Motor Assessment6	X
Respiratory Assessment7	X
Cognitive Assessment9	X

¹Screening assessments to be completed sufficiently in advance to enable randomisation and dosing within 72 hours 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.

²Randomisation to be completed sufficiently in advance to enable starting IMP dosing within 72 h of birth.

³Initial trial drug administrations to be given soon after randomisation, after 6 hours of age and within 72 hours of birth. Subsequent doses to be administered 24 hours after the initial dose.

⁴Only adverse events which are serious will be recorded from first dose until 7 days after trial medication. Only unforeseeable SAEs will be reported.

⁵Concomitant 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.

⁶Gross motor, cognitive, visual and hearing function will be assessed using the PARCA-R questionnaire, expanded to include questions to assess visual and hearing function.

⁷Respiratory assessments will be performed using a separate validated questionnaire. There will be no requirement for the infants to be assessed for respiratory and/or other neurodevelopmental functions by medically qualified personnel.

⁸An 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.

⁹Demography and medications at 2 years will be assessed through the PARCA-R and other questionnaires.

¹⁰If a baby transfers from the recruiting site to a continuing care site for on-going care details of any scan would be helpful.