Persistent ductus arteriosus haemodynamically significant
Conditions
Interventions
Product Name: Paracetamol
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Paracetamol
CAS Number: 103-90-2
Other descriptive name: PARACETAMOL
Concentration unit: mg/ml milligram(s)/m
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2. Set the pharmacokinetics and pharmacodynamics of paracetamol in the neonatal period in infants with persistent ductus. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Security: 1. Incidence of early complications: oliguria, renal failure, necrotizing enterocolitis, intraventricular hemorrhage, hyperbilirubinemia, gastrointestinal bleeding or perforation. 2. Incidence of late complications: bronchopulmonary dysplasia, periventricular leukomalacia, necrotizing enterocolitis, retinopathy of the newborn, sepsis, death Pharmacokinetics: 1. Determination of plasma levels of paracetamol 2. Pharmacodynamics of paracetamol in the ductus. pharmacokinetic model 3. Relationship plasma levels effectively / adverse reactions Biomarkers and polymorphisms 1. Determination of biomarkers and polymorphisms in urine 2. Relationship disposal / drug metabolism;Timepoint(s) of evaluation of this end point: Early complications: during treatment Late complications: until discharge | — |
Countries
Spain
Outcome results
None listed