Protocol

View the complete protocol: 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.

Bliss News

Read inspiring stories about premature and sick babies from the Bliss website

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