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

NCT04037514 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Patent Ductus Arteriosus After Premature Birth

Interventions

DRUG

Paracetamol

Intravenous paracetamol 15 mg/kg/6h

DRUG

Ibuprofen

Intravenous ibuprofen 10 mg/kg/24h (day 1) and 5 mg/kg/24h (day 2 and 3)

Sponsors & Collaborators

  • Instituto de Investigacion Sanitaria La Fe

    collaborator OTHER

  • Spanish Clinical Research Network - SCReN

    collaborator NETWORK

  • Máximo Vento Torres

    lead OTHER

Principal Investigators

  • Maximo Vento Torres, PhD, MD · Hospital Universitario La Fe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2024-12-18
Completion
2024-12-18

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04037514 on ClinicalTrials.gov