MedTrace Logo

Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)

NCT01630278 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2019-07-08

No results posted yet for this study

Summary

Very premature infants with a large ductus, selected by an early echocardiogram, will receive either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional age. The primary outcome will be survival without cerebral palsy at years.

Conditions

  • Patent Ductus Arteriosus

Interventions

DRUG

Ibuprofen

Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life

DRUG

Placebo

Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Jean-Christophe ROZE, Professor · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • France

Study Locations

More Related Trials

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 NCT01630278 on ClinicalTrials.gov