PatientsVille.com LogoPatientsVille.com

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

Patent Ductus Arteriosus research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Gestational less than 28 weeks - Postnatal age less than 12 hours

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Patent Ductus Arteriosus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Small ductus

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

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

Study Status

Active, not recruiting

Start Date: March 2012

Completed Date: February 2019

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: 2-year survival without cerebral palsy

Secondary Outcome: ASQ (Ages and Stages Questionnaire) score at 2 years

Study sponsors, principal investigator, and references

Principal Investigator: Jean-Christophe ROZE, Professor

Lead Sponsor: Nantes University Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01630278

Discuss Ibuprofene