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Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure

NCT00833365 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-07-04

Study results available
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Summary

The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old.

Conditions

  • Patent Ductus Arteriosus
  • Prematurity

Interventions

DRUG

Ibuprofen

Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose

DRUG

Ibuprofen

Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg

Sponsors & Collaborators

Principal Investigators

  • Gary Chan, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
96 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00833365 on ClinicalTrials.gov