Randomised Placebo-Controlled Trial of Early Targeted Treatment of Patent Ductus Arteriosus with Paracetamol in Extremely Low Birth Weight Infants

Patent Ductus Arteriosus (PDA) is common in newborn infants, especially premature infants. During pregnancy, the Ductus Arteriosus is an open channel between the two main blood vessels coming from the baby's heart. After birth it usually closes during the first few days. For very premature babies it may take longer to close, or may not close fully on its own. PDA may not cause any complications for a baby but is linked with bleeding in the lungs and brain, inadequate blood supply to the gut, and death.

Current practice in PDA management varies greatly. Treatment typically starts after the first day of life, which can impact negatively on prevention of early complications, and does not have documented beneficial effect on long term outcome. Early precautionary medical treatment has shown a reduction in early complications, but may unnecessarily expose infants to potentially harmful medication.

Currently the most common treatment for PDA includes Indomethacin and/or Ibuprofen. Both of these medicines can be potentially harmful to the brain, gut and kidneys. Recently Paracetamol has been identified as an alternative treatment, with fewer side effects.

In premature babies, born <1000g, we will carry out heart ultrasound scans between 6 and 12 hours of age to detect PDA. For PDA's that meet our criteria Paracetamol (treatment) or salt-water solution (placebo) will be given four times a day intravenously until the PDA closes, or to a total of six days. We will compare results between the two groups to see which group had better outcomes. We will not know who has received treatment/placebo. We aim to show that treating babies early with Paracetamol, based on specific criteria, is safer than waiting to treat their PDA when they develop complications, and will result in significant reduction in known consequences of PDA for their survival and long-term health
 

Award Date

04 December 2020

Award Value

€€718,576.47

Principal Investigator

Professor Jan Miletin

Host Institution

University College Dublin

Scheme

DIFA 2020