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High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant

NCT01243996 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2010-11-19

No results posted yet for this study

Summary

The investigators hypothesized that the early treatment of PDA with ibuprofen doses higher than those actually recommended might increase the closure rate in preterm infants with gestational age \<29 weeks without increasing the occurrence of associated adverse effects. To assess this hypothesis the investigators planned a multicenter randomized controlled study to compare the effectiveness of the current ibuprofen regimen to that of a high-dose regimen in closing PDA.

Conditions

  • Ductus Arteriosus, Patent

Interventions

DRUG

Ibuprofen

Treatment with high (20-10-10 mg/kg/day)or standard dose(10-5-5 mg/kg/day) ibuprofen

Sponsors & Collaborators

  • University of Florence

    lead OTHER

Principal Investigators

  • Carlo Dani, MD · University of Florence, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Hours
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-05-31
Completion
2010-10-31

Countries

  • Italy

Study Locations

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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 NCT01243996 on ClinicalTrials.gov