Babies born preterm commonly have a condition called Patent Ductus Arteriosus (PDA). This is when the blood vessel Ductus Arteriosus, which allows blood to bypass the baby's developing lungs and reach the mother's placenta during pregnancy, remains open after birth. PDA is associated with a number of serious and life-threatening short and long term complications.
In the UK, approximately 7,000 babies are born extremely preterm each year. Of these around 40% will have a PDA. In some, the condition will disappear on its own but in others treatment may be needed. The condition can be treated with ibuprofen, but giving extremely preterm babies can result in significant complications.
Medical opinion is therefore divided on how best to care for extremely preterm babies with a PDA. Some doctors believe it is better to treat with ibuprofen as a precaution, but others believe it is better to wait until PDA symptoms appear. Treating all babies inevitably means some will be exposed unnecessarily to the potentially harmful side effects of ibuprofen, whilst not treating until symptoms develop may be too late, as the condition may already have caused irreversible damage.
In this trial, babies will be randomly allocated to receive either treatment with ibuprofen or a matched placebo of saline. The ibuprofen formulation that will be used in this study has been approved for the treatment of PDA in premature babies. Neither parents nor staff caring for a baby will know which treatment has been allocated. This is to make sure that the treatments are compared fairly, and to prevent the results of the study being biased
Research and clinical trials are an everyday part of the NHS. The people who do research are mostly the same doctors and other health care professionals who treat people. They want to find better ways of looking after patients. Sometimes there are uncertainties in the best care for patients – filling these knowledge gaps is vital, as research helps advance technologies and treatment, helping more babies survive.
If you would like to contact an independent organisation, we suggest that you contact Bliss, a special care baby charity. Bliss website Tel: 020 7378 1122; Email:firstname.lastname@example.org