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Table 3 Trial assessments

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

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  
  1. 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
  2. bRandomisation to be completed sufficiently in advance to enable dosing within 72 h of birth
  3. 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
  4. dOnly adverse events which are serious will be recorded from first dose until 7 days after trial medication. Only unforeseeable SAEs will be reported
  5. 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
  6. 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
  7. gDemography and medications will be assessed through the PARCA-R and other questionnaires
  8. hIf a baby transfers from the recruiting site to a continuing care site for on-going care details of any scan would be helpful