The Baby-Oscar trial have published their study protocol
The Baby-Oscar trial have recently published their Study Protocol in BMC Pediatrics.
The aim of this study is to find out whether or not a large Patent Ductus Arteriosus (PDA) in very premature babies should be treated with ibuprofen within 72 hours of birth. Ibuprofen is a NSAID (non-steroidal anti-inflammatory drug) that is commonly used for pain relief in adults.
PDA is a condition that is caused by a blood vessel called the Ductus Arteriosus staying open after a baby's birth (patent here means open). During pregnancy, the Ductus Arteriosus allows blood from the baby's heart to flow to the mother's placenta to get oxygen, bypassing the baby's lungs. Soon after birth the ductus should close to allow blood to flow to the baby's own lungs to get oxygen. However in very premature babies the ductus often takes a long time to close on its own and this can lead to a variety of complications. Doctors are unsure if early treatment should be offered to very premature babies to close the PDA and reduce the risks of complications, or whether it would be better to wait and see (the conservative approach) if the ductus will close on its own.
PDA can be treated with medicines such as ibuprofen. However, treatment with ibuprofen can itself cause problems because premature babies may not be able to cope with its side effects. In addition, the PDA may not cause any problems. Doctors are therefore unsure whether to treat with ibuprofen as a precaution or to wait until symptoms develop, by which time some harm may have already been done.
Parents of very premature babies (born between 23 weeks and less than 29 weeks of pregnancy), who are less than 72 hours old and confirmed with an echocardiogram to have a large PDA are invited to take part in the study.
Once consent has been given, the baby's details are entered into a computer programme which randomly selects whether the baby will receive ibuprofen or placebo (saline) which is given in 3 doses 24 hours apart. The baby then has an echocardiogram at 3 weeks of age to determine if the PDA has closed and an assessment is carried out at 36 weeks of age to determine the baby's oxygen requirements.
As a follow up and to determine the long term effects of PDA, the parents of the infant are sent a questionnaire at 2 years of age looking at the child's development. This is a really important part of the study to determine survival with or without long term respiratory morbidity and neurodevelopmental disability.