Protocol

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Baby-OSCAR Version 6

Baby-OSCAR

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.

Diagram Description

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.

Funding Acknowledgement: This project is funded by the National Institute of Health Research – Health Technology Assessment Programme (project reference 11/92/15)

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