View the complete protocol:
Outcome after Selective Early Treatment for Closure of Patent Ductus ARteriosus in Pre-term Babies
A multi-centre randomised placebo controlled trial of ibuprofen for extremely preterm babies with a large Patent Ductus Arteriosus.
This diagram is a schematic representation of the Baby-OSCAR Trial. It is divided into 3 stages: pre-intervention, intervention and post-intervention.
The pre-intervention stage is divided into 5 steps: preterm infant, standard ECHO assessment to detect a large PDA, assessment for eligibility, obtaining parental consent and then randomisation.
The intervention stage shows the 2 possible interventions that a baby in the trial might receive: either ibuprofen, or a matched placebo. Treatment would start within 72 hours of birth and would typically stop 72 hours later.
The post-intervention stage shows that after ibuprofen or placebo intervention is completed, the baby is discharged from hospital.
Follow-up at 2 years of age corrected for prematurity is planned to assess the health of the child and how they are developing.