Trial · NCT04037514
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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 |
| Secondary | Pharmacodynamics model of paracetamol in the context of hsPDA: Maximum Plasma Concentration [Cmax] | 24-48 hours after the completion of study intervention | Relation of effectiveness/adverse reactions to serum levels |
| Secondary | Pharmacodynamics model of paracetamol in the context of hsPDA: Minimum Plasma Concentration [Cmin] | 24-48 hours after the completion of study intervention | Relation of effectiveness/adverse reactions to serum levels |
| Secondary | Pharmacodynamics model of paracetamol in the context of hsPDA: Area Under the Curve [AUC]) | 24-48 hours after the completion of study intervention | Relation of effectiveness/adverse reactions to serum levels |
| Secondary | Pharmacodynamics model of paracetamol in the context of hsPDA: urine metabolites | 24-48 hours after the completion of study intervention | Quantification of metabolites in urine and its relationship with drug elimination/metabolism |
| Secondary | Pharmacogenetics of paracetamol | 24-48 hours after the completion of study intervention | Genetic polymorphisms in TFAP2B, TGFBR2, EPAS1, MD-2 and GM2A genes related to efficacy/occurrence of adverse reactions |
| Secondary | Price-effectiveness ratio. Cost-effectiveness analysis depending on the efficiency obtained in the treatment. | from randomization until discharge, an average of 2 months | |
| Secondary | Genotoxicity mesured by %DNA damage | from randomization until discharge, an average of 2 months |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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