In short
There are currently 2 clinical trials investigating treatments for Patent Ductus Arteriosus in extremely premature and low birth weight infants. These studies are testing medications including Paracetamol (Acetaminophen) and Ibuprofen to help close the ductus arteriosus blood vessel that should close after birth but remains open in this condition. The trials are being conducted in Czechia and Ireland.
Clinical trial locations
- Czechia
- Ireland
Study on Early Treatment of Patent Ductus Arteriosus with Paracetamol in Extremely Low Birth Weight Infants
This trial is investigating whether early treatment with Paracetamol can help extremely low birth weight infants with Patent Ductus Arteriosus. The ductus arteriosus is a blood vessel that normally closes after birth, but when it remains open, it can lead to serious heart and lung problems in vulnerable infants.
Who can join this trial:
- Newborns weighing less than 1000 grams at birth
- Infants for whom the medical team has decided to provide intensive care
- Infants with a large Patent Ductus Arteriosus, confirmed by a heart ultrasound performed between 6 and 12 hours after birth, showing a vessel diameter greater than 1.5 millimeters with free blood flow
Who cannot join this trial:
- Infants with a known allergy to Paracetamol
- Those with severe liver or kidney problems
- Infants who have received another investigational drug within the last 30 days
- Those with a serious infection requiring antibiotic treatment
- Infants with a known bleeding disorder
- Those who have had major surgery within the last 7 days
- Infants with a known heart defect other than Patent Ductus Arteriosus
What the trial involves:
The study compares Paracetamol given through an infusion directly into the bloodstream with a placebo. The treatment is administered at a dosage of 10mg/ml for up to six days. Researchers will closely monitor whether early Paracetamol treatment can reduce the risk of serious complications including bleeding in the brain, severe intestinal conditions, and death before hospital discharge.
Investigational drug: Paracetamol, commonly used to relieve pain and reduce fever, is being tested for its potential to treat Patent Ductus Arteriosus by helping the blood vessel close properly. The trial aims to determine if this early intervention can prevent life-threatening complications in extremely vulnerable infants.
Study on the Use of Ibuprofen and Paracetamol for Treating Patent Ductus Arteriosus in Extremely Premature Infants
This trial is exploring whether combining two medications, Ibuprofen and Acetaminophen (also known as Paracetamol), works better than using Ibuprofen alone to treat Patent Ductus Arteriosus in extremely premature infants. The goal is to find a more effective treatment approach that can improve health outcomes for these vulnerable babies.
Who can join this trial:
- Preterm infants born before 27 weeks of pregnancy
- Infants whose parents have given consent after approval from the attending doctor
- Those with a Patent Ductus Arteriosus measuring 1.5 mm or more on echocardiogram, with blood flowing mainly from left to right
- Infants scheduled to receive their first treatment with intravenous or enteral Ibuprofen as decided by the medical team
Who cannot join this trial:
- Patients with a history of allergic reactions to Ibuprofen or Acetaminophen
- Those with severe liver or kidney problems
- Patients with active bleeding disorders
- Those currently taking other medications that might interact with Ibuprofen or Acetaminophen
- Patients with severe heart conditions
- Those who have participated in another clinical trial within the last 30 days
- Patients unable to comply with study procedures or follow-up visits
What the trial involves:
Participants will be randomly assigned to receive either the combination treatment of Ibuprofen and Acetaminophen or Ibuprofen alone. Both medications are given through an intravenous line. Throughout the trial, the medical team will closely monitor the infants' heart, lungs, and overall health. Researchers will track whether the treatment successfully closes the ductus arteriosus, monitor kidney and liver function, and assess respiratory support needs.
Investigational drugs: Ibuprofen is a medication that reduces pain, inflammation, and fever. It works by blocking substances in the body that cause inflammation and is used to encourage closure of the ductus arteriosus. Acetaminophen (Paracetamol) is being tested in combination with Ibuprofen to see if this dual approach can more effectively close the blood vessel and reduce the risk of serious lung complications called bronchopulmonary dysplasia or death in extremely premature infants.
Summary
Both clinical trials focus on treating Patent Ductus Arteriosus in the most vulnerable infant population: those born extremely prematurely or with very low birth weight. The condition occurs when a crucial blood vessel fails to close after birth, potentially causing serious heart and lung complications.
The trials are testing different medication approaches. The first study evaluates whether early treatment with Paracetamol alone can prevent serious complications in infants weighing less than 1000 grams. The second study compares the combination of Ibuprofen and Paracetamol against Ibuprofen alone in infants born before 27 weeks of pregnancy.
Ireland appears in both trials, making it a significant location for this research, while Czechia participates in the Paracetamol-focused study. Both trials are expected to provide valuable insights into optimal treatment approaches for this serious heart condition in extremely premature infants, potentially leading to improved survival rates and better long-term health outcomes for these vulnerable patients.
