Clinical Trials Logo
  1. Home
  2. Patent Ductus Arteriosus
  3. NCT01630278
  4. Details
NCT01630278 Clinical Trial

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

Patent Ductus Arteriosus Clinical Trial

— TRIOCAPI  

Official title:
Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01630278
Other study ID # BRD/10/06-O
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2012
Est. completion date June 2019

Study information
Verified date July 2019
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 363
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Weeks
Eligibility Inclusion Criteria:

- Gestational less than 28 weeks

- Postnatal age less than 12 hours

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ibuprofen
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
• Placebo
Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life

Locations
Country Name City State
France University Hopsital Angers
France University Hopsital Bordeaux
France University Hospital Créteil
France University Hospital Grenoble
France University Hospital Lille
France University Hospital Marseille
France Univesity Hospital Montpellier
France University Hospital Nantes
France University Hospital (AP-HP Groupe hospitalier) Paris
France University Hospital Rennes
France University Hospital Tours

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 2-year survival without cerebral palsy 2 years
Secondary ASQ (Ages and Stages Questionnaire) score at 2 years 2 years
Secondary Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal) To compare the outcome between the large and the small ductus groups 2 years
Secondary Comparison of outcome according to the McNamara stage at surgical ligation 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT04986839 - PAIR (Paracetamol and Ibuprofen Research) Pilot Trial Phase 2/Phase 3
Recruiting NCT03648437 - Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus Phase 1
Completed NCT04126512 - Timing of Surgical PDA Ligation and Neonatal Outcomes
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Completed NCT00217191 - Ibuprofen and Renal Function in Premature Infants Phase 4
Not yet recruiting NCT02894970 - A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation N/A
Completed NCT02621528 - Lifetech CeraFlex™ Post-Market Surveillance Study N/A
Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Terminated NCT03982342 - Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants N/A
Completed NCT01479218 - Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus N/A
Completed NCT00795990 - Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants N/A
Withdrawn NCT00554307 - Brain, Gut and Kidney Blood Flow During Medical Closure of PDA N/A
Terminated NCT00802685 - Timing of PDA Closure and Respiratory Outcome in Premature Infants N/A
Completed NCT03723889 - Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
Recruiting NCT04397913 - Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
Completed NCT02750228 - PDA Post NICU Discharge
Recruiting NCT02220270 - Hyperion™ International Registry Trial N/A
Completed NCT01593163 - Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus Phase 3
Completed NCT03277768 - Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
Completed NCT03022253 - Platelet Transfusion for Treatment of Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates Phase 3