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Study on the Use of Ibuprofen and Paracetamol for Treating Patent Ductus Arteriosus in Extremely Premature 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 extremely premature infants. PDA is a condition where a blood vessel called the ductus arteriosus fails to close after birth, which can lead to heart and lung problems. The study will explore the effects of using a combination of two medications, Ibuprofen and Acetaminophen (also known as Paracetamol), compared to using Ibuprofen alone, which is the current standard treatment.

The purpose of the study is to evaluate whether the combination of these medications can improve health outcomes for these infants. The study will involve administering these medications intravenously, which means they will be given directly into a vein. The trial will last for a short period, with the treatment being given over a few days. The researchers aim to see if the combination treatment can reduce the chances of developing a lung condition called bronchopulmonary dysplasia or reduce the risk of death in these infants.

Participants in the study will be monitored for various health outcomes, including the success of PDA treatment, any changes in kidney or liver function, and the need for additional treatments. The study will also track the infants' respiratory support needs and any other health issues that may arise during their stay in the neonatal intensive care unit. The goal is to find a more effective treatment approach for PDA in extremely premature infants, potentially leading to better health outcomes for these vulnerable patients.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the study, you will be informed about the trial's purpose and procedures. Consent from your parents or guardians is required before participation.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm the diagnosis of patent ductus arteriosus (PDA). This involves an echocardiography, a type of ultrasound that checks the heart and nearby blood vessels.

  3. Step 3

    Treatment allocation

    You will be assigned to receive either the combination treatment of ibuprofen and acetaminophen or ibuprofen alone. This decision is made randomly to ensure fairness in the study.

  4. Step 4

    Medication administration

    If you are in the combination treatment group, you will receive ibuprofen and acetaminophen through an intravenous (IV) line. The dosage and frequency will be determined by the medical team based on your specific needs.

    If you are in the ibuprofen alone group, you will receive only ibuprofen through an IV line.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, your health will be closely monitored. This includes regular checks on your heart, lungs, and overall well-being. The medical team will assess the effectiveness of the treatment and any side effects.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment period, a final evaluation will be conducted to determine the success of the treatment. This includes checking if the PDA has closed or become insignificant.

  7. Step 7

    Post-trial follow-up

    After the trial, there will be follow-up visits to monitor your health and development. This ensures any long-term effects of the treatment are identified and managed appropriately.

Who can join the trial?

4 criteria

  • Preterm infants born before 27 weeks of pregnancy.
  • Permission from the attending doctor to approach the parents, and consent obtained from the parents.
  • Diagnosis of Patent Ductus Arteriosus (PDA) with a size of 1.5 mm or more, as seen on an echocardiogram (a heart ultrasound), with blood flowing mainly from left to right.
  • Scheduled to receive the first treatment with either intravenous (through a vein) or enteral (through the digestive system) ibuprofen, as decided by the medical team.

Who cannot join the trial?

7 criteria

  • Patients with a history of **allergic reactions** to **Ibuprofen** or **Acetaminophen** cannot participate. An allergic reaction is when your body reacts badly to a substance, causing symptoms like rash, itching, or swelling.
  • Patients who have **severe liver or kidney problems** are not eligible. The liver and kidneys are important organs that help clean your blood and remove waste from your body.
  • Patients with **active bleeding disorders** cannot join. A bleeding disorder is a condition that affects the way your blood clots, which can lead to excessive bleeding.
  • Patients who are currently taking other medications that might interact with **Ibuprofen** or **Acetaminophen** are excluded. Some medications can cause harmful effects when taken together.
  • Patients with **severe heart conditions** are not allowed to participate. The heart is a vital organ that pumps blood throughout your body, and severe conditions can affect its function.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible. This is to ensure that the results of this study are not affected by other treatments.
  • Patients who are unable to comply with the study procedures or follow-up visits are excluded. This means that if you cannot attend all the required appointments or follow the study instructions, you cannot participate.
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Investigated drugs

  • Ibuprofen

    is a medication commonly used to reduce pain, inflammation, and fever. In this clinical trial, it is being used to treat a condition called patent ductus arteriosus (PDA) in extremely premature infants. PDA is a heart problem that occurs when a blood vessel called the ductus arteriosus does not close as it should after birth. Ibuprofen helps by encouraging the closure of this vessel, which can improve heart and lung function in these infants.

  • Acetaminophen

    , also known as paracetamol, is a medication often used to relieve pain and reduce fever. In this trial, it is being administered intravenously, meaning it is given directly into a vein. The study is exploring whether using acetaminophen together with ibuprofen can improve outcomes for extremely premature infants with PDA. The goal is to see if this combination can more effectively close the ductus arteriosus and reduce the risk of complications like bronchopulmonary dysplasia, a serious lung condition, or death.

What is already known about the treatment

  • Acetaminophen

    Acetaminophen is administered intravenously and is currently being studied in combination with Ibuprofen to treat patent ductus arteriosus (PDA) in extremely premature infants. This medication is well-known in medical literature for its pain-relieving and fever-reducing properties. In this trial, it is used to improve outcomes related to PDA by potentially reducing the incidence of bronchopulmonary dysplasia or death. At the molecular level, acetaminophen works by inhibiting the production of certain chemicals in the brain that cause pain and fever. It is classified as an analgesic and antipyretic.

  • Ibuprofen

    Ibuprofen is administered orally or intravenously and is a standard treatment for patent ductus arteriosus (PDA) in extremely premature infants. It is widely recognized in medical literature for its ability to reduce inflammation, pain, and fever. In this trial, it is being evaluated in combination with acetaminophen to enhance treatment outcomes for PDA. Ibuprofen works by blocking the production of substances in the body that cause inflammation and pain. It is classified as a nonsteroidal anti-inflammatory drug (NSAID).

Investigated diseases

Patent ductus arteriosus (PDA) – Patent ductus arteriosus is a heart condition that occurs when a blood vessel called the ductus arteriosus fails to close after birth. Normally, this vessel closes shortly after birth, but in PDA, it remains open, allowing blood to flow between the aorta and the pulmonary artery. This can lead to increased blood flow to the lungs and heart, causing strain on these organs. Over time, the condition can result in symptoms such as difficulty breathing, poor feeding, and failure to thrive in infants. If left unaddressed, it may lead to complications like heart enlargement or pulmonary hypertension. The progression of PDA varies, with some cases resolving on their own while others may persist and require medical intervention.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2023-503209-13-00Estimated enrolment310 patientsSponsorRoyal College Of Surgeons In Ireland

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