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Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial

NCT01536158 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-12-27

No results posted yet for this study

Summary

The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.

Conditions

  • Patent Ductus Arteriosus

Interventions

DRUG

Oral paracetamol

Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.

DRUG

Oral ibuprofen

Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

Sponsors & Collaborators

  • Zekai Tahir Burak Women's Health Research and Education Hospital

    lead OTHER

Principal Investigators

  • Mehmet Yekta Oncel, MD · Zekai Tahir Burak Women's Health Research and Education Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT01536158 on ClinicalTrials.gov