Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus … (NCT04037514) | Clinical Trial Compass
CompletedPhase 3
Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus
Spain133 participantsStarted 2017-07-07
Plain-language summary
Multicentric, double-blind clinical trial, which will evaluate the efficacy of iv paracetamol versus standard treatment with ibuprofen in the closure of patent ductus arteriosus in the preterm newborn. Secondarily, we intend to compare the safety of both treatments, increase our knowledge about the pharmacokinetics, pharmacodynamics and pharmacogenetics of paracetamol and ibuprofen in the neonatal period and make a pharmacoeconomic assessment of the use of both drugs.
Who can participate
Age range
14 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written Informed consent of parents/guardians
* Gestacional Age ≤30 weeks
* Postnatal age ≤ 2 weeks
* Need for ventilatory support
* Born in participating hospital/arrival to them within the period of application of the treatment
* 1 st episode of hemodynamically significant Patent Ductus Arteriosus
Exclusion Criteria:
* Major congenital malformations or chromosomopathies
* Refusal to participate and / or sign the informed consent.
* Impossibility or erroneous randomization
* Participation in another clinical trial with drugs
* Diuresis less than 1 ml / kg / h for 8 h prior to treatment
* Greater than 1.8 mg / dl Creatinine
* Platelets below 50,000 / uL
* Active bleeding (tracheal, gastrointestinal and renal)
* Intraventricular hemorrhage recently (48h) (grades 3-4)
* Severe hyperbilirubinemia
* Liver failure or severe coagulopathy
* Active necrotizing enterocolitis or intestinal perforation
* Septic shock
* Imminent death
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of closure of the hsPDA after treatment with paracetamol (experimental drug) versus ibuprofen (control drug).
Timeframe: 24-48 hours after the completion of study intervention