Patent Ductus Arteriosus After Premature BirthPhase 3IBUPARNCT04037514
Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus
A Phase 3 study testing Paracetamol and Ibuprofen in people with Patent Ductus Arteriosus After Premature Birth, run by Máximo Vento Torres at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 14 days
- Conditions the study is for
- Patent Ductus Arteriosus After Premature Birth
- What is being tested?
- Paracetamol and Ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 4 sitesSpain
- Study dates
- 7 Jul 2017to 18 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Reina Sofía
Córdoba, Cordoba
Hospital Universitario de Cabueñes
Gijón, Gijón
Hospital Materno-Infantil (Hospital Regional Carlos Haya) Málaga:
Málaga, Málaga
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026
About this study
Official title: Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus: a Randomized Clinical Trial
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.
Read the detailed description
Those newborns ≤ 30 weeks of gestational age who are diagnosed in the first 2 weeks of hemodynamically significant ductus arteriosus and who do not meet any exclusion criteria will be eligible to participate in the study.
The PARACETAMOL group will receive intravenous doses of 15 mg/kg administered every 6h for 3 days (up to a maximum of 2 courses, i.e. 6 days). The IBUPROFEN group (control group) will receive the usual treatment, this is an initial dose of 10 mg/kg followed by 5 mg/kg intravenously at 24 and 48 hours after the first (all three doses are considered a treatment course), up a maximum of 2 courses).
A daily echocardiographic control will be performed to evaluate the closure of the ductus. If the ductus remains open and with significant clinical repercussion after completing a 3-day course of treatment, another batch of 3 doses of the same treatment will be administered. If medical treatment fails after two courses (6 days), the possibility of administering a batch of Ibuprofen at usual doses in both groups with the intention of offering standard treatment to all patients will be considered. Once the medical treatment with both drugs is completed if the ductus remains significant, the surgical closure will be carried out.
- Being tested
- Paracetamol, Ibuprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Intravenous paracetamol 15 mg/kg/6h
IbuprofenDrug
Intravenous ibuprofen 10 mg/kg/24h (day 1) and 5 mg/kg/24h (day 2 and 3)
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Experimental | Intravenous paracetamol 15 mg/kg/6h for 3 or 6 days Receives: Drug: Paracetamol |
| Ibuprofen | Active comparator | Intravenous ibuprofen 10 mg/kg/24 h (day 1) and 5 mg/kg/24h (day 2 and 3) for 3 or 6 days Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of closure of the hsPDA after treatment with paracetamol (experimental drug) versus ibuprofen (control drug).
It will include the closure rate after the first course of treatment, considered as ductus diameter \< 1 mm monitored by echocardiography performed by a pediatric cardiology specialist.
Measured: 24-48 hours after the completion of study intervention
Secondary outcomes (16)
Need for a second course of treatment
Measured: from randomization until discharge, an average of 2 months
Closure rate after two treatment courses
Measured: from randomization until discharge, an average of 2 months
Need for rescue treatment after two courses of treatment
Measured: from randomization until discharge, an average of 2 months
Reopening rate after closure
Measured: from randomization until discharge, an average of 2 months
Closing rate after reopening
Measured: from randomization until discharge, an average of 2 months
Time required until closing
Measured: from randomization until discharge, an average of 2 months
Need for surgical ligation
Measured: from randomization until discharge, an average of 2 months
Incidence of early complications
oliguria, renal failure, necrotizing enterocolitis, intraventricular hemorrhage, hyperbilirubinemia, gastrointestinal bleeding or perforation
Measured: from randomization until discharge, an average of 2 months
Incidence of late complications
bronchopulmonary dysplasia, periventricular leukomalacia, necrotizing enterocolitis, retinopathy of the newborn, neurodevelopmental assessment, sepsis, death
Measured: from randomization until 2 years
Pharmacodynamics model of paracetamol in the context of hsPDA: Maximum Plasma Concentration [Cmax]
Relation of effectiveness/adverse reactions to serum levels
Measured: 24-48 hours after the completion of study intervention
Pharmacodynamics model of paracetamol in the context of hsPDA: Minimum Plasma Concentration [Cmin]
Relation of effectiveness/adverse reactions to serum levels
Measured: 24-48 hours after the completion of study intervention
Pharmacodynamics model of paracetamol in the context of hsPDA: Area Under the Curve [AUC])
Relation of effectiveness/adverse reactions to serum levels
Measured: 24-48 hours after the completion of study intervention
Pharmacodynamics model of paracetamol in the context of hsPDA: urine metabolites
Quantification of metabolites in urine and its relationship with drug elimination/metabolism
Measured: 24-48 hours after the completion of study intervention
Pharmacogenetics of paracetamol
Genetic polymorphisms in TFAP2B, TGFBR2, EPAS1, MD-2 and GM2A genes related to efficacy/occurrence of adverse reactions
Measured: 24-48 hours after the completion of study intervention
Price-effectiveness ratio. Cost-effectiveness analysis depending on the efficiency obtained in the treatment.
Measured: from randomization until discharge, an average of 2 months
Genotoxicity mesured by %DNA damage
Measured: from randomization until discharge, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start7 Jul 2017
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus Arteriosus After Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Máximo Vento Torres
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe, Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor-investigator, Máximo Vento Torres, Instituto de Investigacion Sanitaria La Fe
- Investigators
- Maximo Vento Torres, PhD, MD, Study chair, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037514
- Sponsor's protocol ID
- IBUPAR-TRIAL
- Acronym
- IBUPAR
- Status last verified
- Dec 2025
- First submitted
- 23 Jul 2019
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dang D, Wang D, Zhang C, Zhou W, Zhou Q, Wu H. Comparison of oral paracetamol versus ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial. PLoS One. 2013 Nov 4;8(11):e77888. doi: 10.1371/journal.pone.0077888. eCollection 2013.
PubMed 24223740Hammerman C, Bin-Nun A, Markovitch E, Schimmel MS, Kaplan M, Fink D. Ductal closure with paracetamol: a surprising new approach to patent ductus arteriosus treatment. Pediatrics. 2011 Dec;128(6):e1618-21. doi: 10.1542/peds.2011-0359. Epub 2011 Nov 7.
PubMed 22065264Oncel MY, Yurttutan S, Erdeve O, Uras N, Altug N, Oguz SS, Canpolat FE, Dilmen U. Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial. J Pediatr. 2014 Mar;164(3):510-4.e1. doi: 10.1016/j.jpeds.2013.11.008. Epub 2013 Dec 18.
PubMed 24359938Yang B, Gao X, Ren Y, Wang Y, Zhang Q. Oral paracetamol vs. oral ibuprofen in the treatment of symptomatic patent ductus arteriosus in premature infants: A randomized controlled trial. Exp Ther Med. 2016 Oct;12(4):2531-2536. doi: 10.3892/etm.2016.3676. Epub 2016 Sep 6.
PubMed 27698754Dash SK, Kabra NS, Avasthi BS, Sharma SR, Padhi P, Ahmed J. Enteral paracetamol or Intravenous Indomethacin for Closure of Patent Ductus Arteriosus in Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2015 Jul;52(7):573-8. doi: 10.1007/s13312-015-0677-z.
PubMed 26244949Sancak S, Gokmen Yildirim T, Topcuoglu S, Yavuz T, Karatekin G, Ovali F. Oral versus intravenous paracetamol: which is better in closure of patent ductus arteriosus in very low birth weight infants? J Matern Fetal Neonatal Med. 2016;29(1):135-9. doi: 10.3109/14767058.2014.989829. Epub 2014 Dec 23.
PubMed 25471090El-Khuffash A, Jain A, Corcoran D, Shah PS, Hooper CW, Brown N, Poole SD, Shelton EL, Milne GL, Reese J, McNamara PJ. Efficacy of paracetamol on patent ductus arteriosus closure may be dose dependent: evidence from human and murine studies. Pediatr Res. 2014 Sep;76(3):238-44. doi: 10.1038/pr.2014.82. Epub 2014 Jun 18.
PubMed 24941212Garcia-Robles A, Gimeno Navarro A, Serrano Martin MDM, Parraga Quiles MJ, Parra Llorca A, Poveda-Andres JL, Vento Torres M, Aguar Carrascosa M. Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol. Front Pediatr. 2020 Jul 17;8:372. doi: 10.3389/fped.2020.00372. eCollection 2020.
PubMed 32766181
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04037514
- Acronym / sponsor ID
- IBUPAR / IBUPAR-TRIAL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Máximo Vento TorresUniversity, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe, Spanish Clinical Research Network - SCReN
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Those newborns ≤ 30 weeks of gestational age who are diagnosed in the first 2 weeks of hemodynamically significant ductus arteriosus and who do not meet any exclusion criteria will be eligible to participate in the study.
The PARACETAMOL group will receive intravenous doses of 15 mg/kg administered every 6h for 3 days (up to a maximum of 2 courses, i.e. 6 days). The IBUPROFEN group (control group) will receive the usual treatment, this is an initial dose of 10 mg/kg followed by 5 mg/kg intravenously at 24 and 48 hours after the first (all three doses are considered a treatment course), up a maximum of 2 courses).
A daily echocardiographic control will be performed to evaluate the closure of the ductus. If the ductus remains open and with significant clinical repercussion after completing a 3-day course of treatment, another batch of 3 doses of the same treatment will be administered. If medical treatment fails after two courses (6 days), the possibility of administering a batch of Ibuprofen at usual doses in both groups with the intention of offering standard treatment to all patients will be considered. Once the medical treatment with both drugs is completed if the ductus remains significant, the surgical closure will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Experimental | Drug: ParacetamolIntravenous paracetamol 15 mg/kg/6h for 3 or 6 days |
| Ibuprofen | Active comparator | Drug: IbuprofenIntravenous ibuprofen 10 mg/kg/24 h (day 1) and 5 mg/kg/24h (day 2 and 3) for 3 or 6 days |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolIntravenous paracetamol 15 mg/kg/6h | Drug | Paracetamol |
| IbuprofenIntravenous ibuprofen 10 mg/kg/24h (day 1) and 5 mg/kg/24h (day 2 and 3) | Drug | Ibuprofen |
Primary outcome
Rate of closure of the hsPDA after treatment with paracetamol (experimental drug) versus ibuprofen (control drug).
Time frame: 24-48 hours after the completion of study intervention
It will include the closure rate after the first course of treatment, considered as ductus diameter \< 1 mm monitored by echocardiography performed by a pediatric cardiology specialist.
16 secondary outcomes
Need for a second course of treatment
Time frame: from randomization until discharge, an average of 2 months
Closure rate after two treatment courses
Time frame: from randomization until discharge, an average of 2 months
Need for rescue treatment after two courses of treatment
Time frame: from randomization until discharge, an average of 2 months
Reopening rate after closure
Time frame: from randomization until discharge, an average of 2 months
Closing rate after reopening
Time frame: from randomization until discharge, an average of 2 months
Time required until closing
Time frame: from randomization until discharge, an average of 2 months
Need for surgical ligation
Time frame: from randomization until discharge, an average of 2 months
Incidence of early complications
Time frame: from randomization until discharge, an average of 2 months
Incidence of late complications
Time frame: from randomization until 2 years
Pharmacodynamics model of paracetamol in the context of hsPDA: Maximum Plasma Concentration [Cmax]
Time frame: 24-48 hours after the completion of study intervention
Pharmacodynamics model of paracetamol in the context of hsPDA: Minimum Plasma Concentration [Cmin]
Time frame: 24-48 hours after the completion of study intervention
Pharmacodynamics model of paracetamol in the context of hsPDA: Area Under the Curve [AUC])
Time frame: 24-48 hours after the completion of study intervention
Pharmacodynamics model of paracetamol in the context of hsPDA: urine metabolites
Time frame: 24-48 hours after the completion of study intervention
Pharmacogenetics of paracetamol
Time frame: 24-48 hours after the completion of study intervention
Price-effectiveness ratio. Cost-effectiveness analysis depending on the efficiency obtained in the treatment.
Time frame: from randomization until discharge, an average of 2 months
Genotoxicity mesured by %DNA damage
Time frame: from randomization until discharge, an average of 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 24223740Dang D, Wang D, Zhang C, Zhou W, Zhou Q, Wu H. Comparison of oral paracetamol versus ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial. PLoS One. 2013 Nov 4;8(11):e77888. doi: 10.1371/journal.pone.0077888. eCollection 2013.
- Background: PubMed 22065264Hammerman C, Bin-Nun A, Markovitch E, Schimmel MS, Kaplan M, Fink D. Ductal closure with paracetamol: a surprising new approach to patent ductus arteriosus treatment. Pediatrics. 2011 Dec;128(6):e1618-21. doi: 10.1542/peds.2011-0359. Epub 2011 Nov 7.
- Background: PubMed 24359938Oncel MY, Yurttutan S, Erdeve O, Uras N, Altug N, Oguz SS, Canpolat FE, Dilmen U. Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial. J Pediatr. 2014 Mar;164(3):510-4.e1. doi: 10.1016/j.jpeds.2013.11.008. Epub 2013 Dec 18.
- Background: PubMed 27698754Yang B, Gao X, Ren Y, Wang Y, Zhang Q. Oral paracetamol vs. oral ibuprofen in the treatment of symptomatic patent ductus arteriosus in premature infants: A randomized controlled trial. Exp Ther Med. 2016 Oct;12(4):2531-2536. doi: 10.3892/etm.2016.3676. Epub 2016 Sep 6.
- Background: PubMed 26244949Dash SK, Kabra NS, Avasthi BS, Sharma SR, Padhi P, Ahmed J. Enteral paracetamol or Intravenous Indomethacin for Closure of Patent Ductus Arteriosus in Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2015 Jul;52(7):573-8. doi: 10.1007/s13312-015-0677-z.
- Background: PubMed 25471090Sancak S, Gokmen Yildirim T, Topcuoglu S, Yavuz T, Karatekin G, Ovali F. Oral versus intravenous paracetamol: which is better in closure of patent ductus arteriosus in very low birth weight infants? J Matern Fetal Neonatal Med. 2016;29(1):135-9. doi: 10.3109/14767058.2014.989829. Epub 2014 Dec 23.
- Background: PubMed 24941212El-Khuffash A, Jain A, Corcoran D, Shah PS, Hooper CW, Brown N, Poole SD, Shelton EL, Milne GL, Reese J, McNamara PJ. Efficacy of paracetamol on patent ductus arteriosus closure may be dose dependent: evidence from human and murine studies. Pediatr Res. 2014 Sep;76(3):238-44. doi: 10.1038/pr.2014.82. Epub 2014 Jun 18.
- Derived from this study: PubMed 32766181Garcia-Robles A, Gimeno Navarro A, Serrano Martin MDM, Parraga Quiles MJ, Parra Llorca A, Poveda-Andres JL, Vento Torres M, Aguar Carrascosa M. Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol. Front Pediatr. 2020 Jul 17;8:372. doi: 10.3389/fped.2020.00372. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maximo Vento Torres, PhD, MD study chair
Hospital Universitario La Fe
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paracetamol and Ibuprofen in people with Patent Ductus Arteriosus After Premature Birth, run by Máximo Vento Torres at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of closure of the hsPDA after treatment with paracetamol (experimental drug) versus ibuprofen (control drug). (time frame: 24-48 hours after the completion of study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04037514, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.