MedTrace Logo

Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates

NCT00961753 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-01-28

No results posted yet for this study

Summary

The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.

Conditions

  • Patent Ductus Arteriosus

Interventions

DRUG

optimized ibuprofen

day of life 0-3 - 10, 5, 5 mg/kg/dose at 24 hour intervals day of life 4-6 - 14, 7, 7 mg/kg/dose at 24 hour intervals day of life 7-29 - 20, 10, 10 mg/kg/dose at 24 hour intervals

DRUG

Standard Ibuprofen

day of life 0-29 - 10,5, 5 mg/kg/dose at 24 hour intervals

Sponsors & Collaborators

  • OSF Healthcare System

    lead OTHER

Principal Investigators

  • James R Hocker, MD · OSF Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
29 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00961753 on ClinicalTrials.gov