Trial · NCT04037514
Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus
NCT04037514, Phase 3, Completed, Máximo Vento Torres
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus. Trials, record NCT04037514. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04037514
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus
- NCT number
- NCT04037514
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 133 participants, actual
- Lead sponsor
- Máximo Vento Torres
- Conditions
- Patent Ductus Arteriosus After Premature Birth
- Interventions
- Paracetamol, Ibuprofen
- First posted
- 2019-07-30
- Last updated
- 2025-12-18
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of closure of the hsPDA after treatment with paracetamol (experimental drug) versus ibuprofen (control drug). | 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. |
| Secondary | Need for a second course of treatment | from randomization until discharge, an average of 2 months | |
| Secondary | Closure rate after two treatment courses | from randomization until discharge, an average of 2 months | |
| Secondary | Need for rescue treatment after two courses of treatment | from randomization until discharge, an average of 2 months | |
| Secondary | Reopening rate after closure | from randomization until discharge, an average of 2 months | |
| Secondary | Closing rate after reopening | from randomization until discharge, an average of 2 months | |
| Secondary | Time required until closing | from randomization until discharge, an average of 2 months | |
| Secondary | Need for surgical ligation | from randomization until discharge, an average of 2 months | |
| Secondary | Incidence of early complications | from randomization until discharge, an average of 2 months | oliguria, renal failure, necrotizing enterocolitis, intraventricular hemorrhage, hyperbilirubinemia, gastrointestinal bleeding or perforation |
| Secondary | Incidence of late complications | from randomization until 2 years | bronchopulmonary dysplasia, periventricular leukomalacia, necrotizing enterocolitis, retinopathy of the newborn, neurodevelopmental assessment, sepsis, death |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04037514
GET https://conductscience.org/api/trials/v1/NCT04037514/registered