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No Treatment Versus Oral Ibuprofen Treatment for Patent Ductus Arteriosus in Preterm Infants

NCT02128191 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2020-01-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of no treatment compared with ibuprofen treatment for patent ductus arteriosus in preterm infants. The study hypothesis is that no treatment is not inferior to oral ibuprofen treatment in preterm infants. (non-inferiority study)

Conditions

  • Bronchopulmonary Dysplasia (BPD)

Interventions

DRUG

Oral ibuprofen

Initial dose of 10 mg/kg of oral ibuprofen, followed by two doses of 5 mg/kg 24 and 48 hours later

DRUG

Normal saline

Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Se In Sung, M.D. · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • South Korea

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 NCT02128191 on ClinicalTrials.gov