Could a common painkiller replace ibuprofen for preemie heart treatment?
NCT ID NCT04037514
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether paracetamol works as well as ibuprofen for closing a common heart duct problem in premature infants. 133 babies born at or before 30 weeks were randomly given one of the two drugs. The goal was to see which drug closes the duct more effectively and safely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- paracetamol and ibuprofen
- What this could lead to
- If paracetamol works as well as ibuprofen, it could offer a safer option for closing a heart duct in premature babies.
- What could go wrong
- This is a completed Phase 3 trial with 133 infants, but results may not apply to all preemies. Both drugs have known side effects, and the duct may still reopen.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
133 people
The number who actually took part.
- Started
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Jul 2017
- Finished
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Dec 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Up to 14 days
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital Materno-Infantil (Hospital Regional Carlos Haya) Málaga:
Málaga, Málaga, Spain
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Hospital Reina Sofía
Córdoba, Cordoba, Spain
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Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026, Spain
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Hospital Universitario de Cabueñes
Gijón, Gijón, Spain
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