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Study on Early Treatment of Patent Ductus Arteriosus with Paracetamol in Extremely Low Birth Weight Infants

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of a heart condition known as Patent Ductus Arteriosus (PDA) in infants with extremely low birth weight. PDA is a condition where a blood vessel called the ductus arteriosus does not close as it should after birth, which can lead to heart and lung problems. The treatment being tested in this study is Paracetamol, a medication commonly used to relieve pain and reduce fever, administered through an infusion directly into the bloodstream.

The purpose of the study is to determine if early treatment with Paracetamol can effectively reduce the risk of complications such as bleeding in the brain, a serious intestinal condition, and death before the infant is discharged from the hospital. The study will compare the effects of Paracetamol with a placebo to see which is more effective. Infants participating in the study will receive the treatment for a period of up to six days.

Throughout the study, the health of the infants will be closely monitored to assess the outcomes. The primary focus will be on the occurrence of significant complications, while secondary outcomes will include the assessment of lung development at 36 weeks and developmental progress at two years of age. This study aims to provide valuable insights into the potential benefits of using Paracetamol for treating PDA in vulnerable infants.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    The study involves infants with a birth weight of less than 1000 grams. The decision to provide intensive care is made by the treating team.

    Infants must have a large Patent Ductus Arteriosus (PDA), which is a heart condition, with specific characteristics determined by an echocardiogram between 6 and 12 hours of age.

  2. Step 2

    Treatment administration

    The treatment involves the administration of Paracetamol through an infusion. The dosage is 10mg/ml, delivered as a solution for infusion.

    The treatment is compared to a placebo to evaluate its effectiveness in reducing certain health outcomes.

  3. Step 3

    Monitoring and assessment

    The primary outcomes being monitored include the severity of certain conditions and overall survival until discharge from the hospital.

    Secondary outcomes include the assessment of chronic lung disease at 36 weeks corrected gestational age and other health indicators at discharge.

  4. Step 4

    Completion of the trial

    The trial is expected to conclude by March 31, 2026.

    The developmental outcome will be assessed at 2 years of corrected gestational age, although this is part of a separate phase not included in the current protocol.

Who can join the trial?

3 criteria

  • Newborns with a birth weight of less than 1000 grams, whether born in the hospital or transferred from other hospitals.
  • The medical team has decided to provide intensive care for the newborn.
  • The newborn has a large **Patent Ductus Arteriosus (PDA)**. This means the PDA has a diameter greater than 1.5 millimeters and allows blood to flow freely, as determined by a special heart ultrasound called **functional neonatal echocardiography (fnECHO)**, done between 6 and 12 hours after birth.

Who cannot join the trial?

8 criteria

  • Infants who have a known allergy to Paracetamol (a common pain reliever and fever reducer).
  • Infants with severe liver problems, as this could affect how the body processes the medication.
  • Infants with severe kidney problems, which could also affect medication processing.
  • Infants who have received another investigational drug within the last 30 days, as this could interfere with the study results.
  • Infants with a serious infection that requires treatment with antibiotics, as this could complicate the study.
  • Infants with a known bleeding disorder, which could increase the risk of complications.
  • Infants who have had a major surgery within the last 7 days, as recovery could affect the study outcomes.
  • Infants with a known heart defect other than Patent Ductus Arteriosus (a condition where a blood vessel in the heart doesn't close as it should after birth).
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Investigated drugs

Paracetamol is being studied in this trial for its potential to treat a condition called Patent Ductus Arteriosus (PDA) in extremely low birth weight infants. The trial aims to see if early treatment with intravenous Paracetamol can help reduce the risk of certain complications, such as bleeding in the brain, a serious intestinal condition, and death before the infants are discharged from the hospital.

What is already known about the treatment

Paracetamol – Paracetamol is administered intravenously in this clinical trial, focusing on its use for treating Patent Ductus Arteriosus (PDA) in extremely low birth weight infants. Currently, it is being studied in a randomized placebo-controlled trial to assess its effectiveness in reducing complications such as brain hemorrhage, intestinal issues, and mortality before hospital discharge. Paracetamol is primarily known for its pain-relieving and fever-reducing properties. It works by inhibiting the production of certain chemicals in the brain that cause pain and fever. It is classified as an analgesic and antipyretic medication.

Investigated diseases

Patent Ductus Arteriosus – This condition occurs when a blood vessel called the ductus arteriosus fails to close after birth, which is a normal process in newborns. The ductus arteriosus is a vital part of fetal circulation, allowing blood to bypass the lungs, but it should close soon after birth as the newborn begins to breathe air. If it remains open, it can lead to abnormal blood flow between the aorta and the pulmonary artery. This can cause increased workload on the heart and lungs, potentially leading to heart failure and other complications. Symptoms may include rapid breathing, poor feeding, and failure to thrive. The condition is more common in premature infants and may resolve on its own or require medical intervention.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-516846-20-00Estimated enrolment228 patientsSponsorUniversity College Dublin

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