Status:
COMPLETED
Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus
Lead Sponsor:
Máximo Vento Torres
Collaborating Sponsors:
Instituto de Investigacion Sanitaria La Fe
Spanish Clinical Research Network - SCReN
Conditions:
Patent Ductus Arteriosus After Premature Birth
Eligibility:
All Genders
Up to 14 years
Phase:
PHASE3
Brief 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...
Detailed Description
Those newborns ≤ 30 weeks of gestational age who are diagnosed in the first 2 weeks of hemodynamically significant ductus arteriosus and who do not meet any exclusion criteria will be eligible to part...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2024
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT04037514
Start Date
July 7 2017
End Date
December 18 2024
Last Update
December 18 2025
Active Locations (4)
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1
Hospital Reina Sofía
Córdoba, Cordoba, Spain
2
Hospital Universitario de Cabueñes
Gijón, Gijón, Spain
3
Hospital Materno-Infantil (Hospital Regional Carlos Haya) Málaga:
Málaga, Málaga, Spain
4
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, Spain, 46026