Paracetamol versus ibuprofen in preterm infants with a hemodynamically significant patent ductus arteriosus: a randomized clinical trial.

Phase 1

Conditions: Persistent ductus arteriosus haemodynamically significant
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2015-003177-14-ES

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

? Informed consent signed by parents or legal representative.
? Gestational age ? 30 weeks.
? Postnatal age ? 2 weeks
? 1st episode of hemodynamically significant PDA diagnosed by ultrasound:
1. Continuous flow through DAP.
2. Retrograde diastolic flow in the descending aorta.
3. Strain the left atrium. (relationship left atrium / aorta (LA / AO)> 1.5).
4. Ductal diameter greater than 1.7 mm.
5. Relationship ductus / descending aorta diameter size greater than 0.5.
? Need for ventilatory support
? Born in participating hospitals or coming to them in the application of the treatment period
Are the trial subjects under 18? yes
Number of subjects for this age range: 396
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Gestational age> 30 weeks
- Postnatal age> 2 weeks
- Major congenital malformations.
- Impending doom.
- Chromosomopaties.
- Refusal to participate and / or sign the informed consent.
- Inability to randomization or scrambling wrong.
- Participation in another clinical trial
- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of the standard treatment of PDA with ibuprofen versus paracetamol in closing the patent ductus arteriosus to determine its non-inferiority to ibuprofen.;Secondary Objective: 1. To compare the safety of both treatments by the rate of early and late complications.<br> 2. Set the pharmacokinetics and pharmacodynamics of paracetamol in the neonatal period in infants with persistent ductus.<br> 3. Study of biomarkers and polymorphisms in urine;Primary end point(s): Non-inferiority incidence of PDA clousure (clousure rate 80%);Timepoint(s) of evaluation of this end point: After a máximum of 6 doses of paracetamol

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Security:<br>1. Incidence of early complications: oliguria, renal failure, necrotizing enterocolitis, intraventricular hemorrhage, hyperbilirubinemia, gastrointestinal bleeding or perforation.<br>2. Incidence of late complications: bronchopulmonary dysplasia, periventricular leukomalacia, necrotizing enterocolitis, retinopathy of the newborn, sepsis, death<br>Pharmacokinetics:<br>1. Determination of plasma levels of paracetamol<br>2. Pharmacodynamics of paracetamol in the ductus. pharmacokinetic model<br>3. Relationship plasma levels effectively / adverse reactions<br>Biomarkers and polymorphisms<br>1. Determination of biomarkers and polymorphisms in urine<br>2. Relationship disposal / drug metabolism;Timepoint(s) of evaluation of this end point: Early complications: during treatment<br>Late complications: until discharge