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Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants

NCT02002741 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-02-18

No results posted yet for this study

Summary

The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Conditions

  • Ductus Arteriosus, Patent

Interventions

DRUG

Paracetamol

Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h

DRUG

Placebo

Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Days
Max Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-01
Primary Completion
2017-05-31
Completion
2017-12-31

Countries

  • Israel

Study Locations

More Related Trials

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 NCT02002741 on ClinicalTrials.gov