PDA Treatment in Premature Infants: Acetaminophen and Ibuprofen Study

We are studying whether combining acetaminophen with ibuprofen helps extremely premature infants with a heart condition. The goal is to see if this combination reduces serious complications compared to ibuprofen alone.

≤3 months Efficacy phase (II)No Placebo Investigational Medicines InjectionCardiologyPediatrics

What diseases are being studied?

Health conditions and diseases that the clinical trial is designed to study and treat.

Who can participate in the clinical trial?

These questions help us understand your situation so we can let the trial team know whether you might be a potential match. This is not a medical evaluation and is not part of the official screening, the study doctor will make the final decision..

What active substances are being studied?

Active substances that are officially approved for use in the European Union and considered safe by EMA. These substances are already on the market and may be tested for new conditions or populations.

Ibuprofen

Ibuprofen is a substance that reduces pain, fever, and inflammation.

Paracetamol

Paracetamol is a substance that relieves pain and reduces fever.

Sodium Chloride

Sodium chloride is a substance used to replace salts and fluids in the body and to clean or irrigate wounds and nasal passages.

What experimental substances are being tested?

Experimental substances that are being investigated in this clinical trial. These are not yet approved for general use.

Pedea

Sodium Chloride

Sponsor: Royal College Of Surgeons In Ireland

Last updated: Nov 27, 2025

Disclaimer: Parts of this content have been automatically extracted from the EU Clinical Trials registry. While we strive for accuracy, please always contact the trial site or sponsor directly for correct and official information before making any decisions about participation. View on EU Clinical Trials.