Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Máximo Vento Torres
• Collaborators: Instituto de Investigacion Sanitaria La Fe; Spanish Clinical Research Network - CAIBER; Spanish Clinical Research Network - SCReN
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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