PAIR (Paracetamol and Ibuprofen Research) Study

• Research type

  Research Study

• Full title

  PAIR (Paracetamol and Ibuprofen Research) Study: A randomised controlled trial comparing intravenous paracetamol with intravenous ibuprofen in the management of haemodynamically significant patent ductus arteriosus in preterm infants

• IRAS ID

  1003574

• Contact name

  Arindam Arindam Mukherjee

• Sponsor organisation

  Manchester University NHS Foundation Trust

• Eudract number

  2020-003863-25

• Research summary

  The ductus arteriosus is an additional blood vessel that connects the pulmonary artery (main vessel supplying the blood to the lungs) to the aorta (main vessel supplying the blood to the body). This connection is present in all babies in the womb but should close shortly after birth. In some babies, especially in those born prematurely, this vessel may remain open. This is called a patent or persistent ductus arteriosus.
  A Patent ductus arteriosus (PDA) can cause problems if it persists after birth by overloading the circulation of blood to the lungs or by diverting blood away from the body potentially reducing oxygen delivery to the other organs. These effects can make it harder for the baby to breathe and can increase the work the heart has to do to pump blood around the body. Some babies do not tolerate having a PDA and can remain or become unwell.
  Medical treatment can be used to help close the PDA. The current practice of medical treatment is the use of intravenous (given by a drip) Ibuprofen for 3 days to narrow or close the PDA. Some research studies have suggested that Intravenous (given by a drip) paracetamol may be equally as effective but with fewer side effects. These studies have been found to be of "low or medium quality". We aim to test this under robust research methodology to is help clinicians make critical life-saving decisions.
  Once enrolled, baby will receive either standard treatment with intravenous ibuprofen or treatment with intravenous paracetamol. An echocardiogram will be performed at the end of 3 days to check if the PDA is starting to close or already closed.
  As this is a pilot trial, we would also collect the information regarding adverse effects caused by either of these medications.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  21/EE/0085

• Date of REC Opinion

  2 Jun 2021

• REC opinion

  Further Information Favourable Opinion