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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01630278
First received: June 11, 2012
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Patent Ductus Arteriosus
Drug: Ibuprofen
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 2-year survival without cerebral palsy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ASQ (Ages and Stages Questionnaire) score at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To compare the outcome between the large and the small ductus groups

  • Comparison of outcome according to the McNamara stage at surgical ligation [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 385
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Small ductus
Experimental: Large ductus ibuprofen
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
Drug: Ibuprofen
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
Placebo Comparator: Large ductus placebo
Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo 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

  Eligibility

Ages Eligible for Study:   up to 28 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational less than 28 weeks
  • Postnatal age less than 12 hours
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630278

Contacts
Contact: Véronique GOURNAY, Professor +33 2 40 08 77 84 veronique.gournay@chu-nantes.fr

Locations
France
University Hopsital Recruiting
Angers, France
Contact: Magali LEBLANC DESHAYES, Doctor       madeshayes-leblanc@chu-angers.fr   
Principal Investigator: Magali LEBLANC DESHAYES, Professor         
University Hopsital Recruiting
Bordeaux, France
Contact: Olivier BRISSAUD, Doctor       olivier.brissaud@chu-bordeaux.fr   
Principal Investigator: Olivier BRISSAUD, Doctor         
University Hospital Recruiting
Créteil, France
Contact: Xavier DURRMEYER, Professor       Xavier.Durrmeyer@chicreteil.fr   
Principal Investigator: Xavier DURRMEYER, Professor         
University Hospital Recruiting
Grenoble, France
Contact: Thierry DEBILLON, Professor       TDebillon@chu-grenoble.fr   
Principal Investigator: Thierry DEBILLON, Professor         
University Hospital Not yet recruiting
Lille, France
Contact: Laurent STORME, Professor       lstorme@chru-lille.fr   
Principal Investigator: Laurent STORME, Professor         
University Hospital Recruiting
Marseille, France
Contact: Umberto SIMEONI, Professor       umberto.simeoni@mail.ap-hm.fr   
Principal Investigator: Umberto SIMEONI, Professor         
Univesity Hospital Recruiting
Montpellier, France
Contact: Gilles CAMBONIE, Professor       g-cambonie@chu-montpellier.fr   
Principal Investigator: Gilles CAMBONIE, Professor         
University Hospital Recruiting
Nantes, France
Contact: Véronique GOURNAY, Professor    +33 2 40 08 77 84    veronique.gournay@chu-nantes.fr   
Principal Investigator: Véronique GOURNAY, Professor         
University Hospital (AP-HP Groupe hospitalier) Recruiting
Paris (Cochin), France
Contact: Juliana PATKAI       juliana.patkai@cch.aphp.fr   
Principal Investigator: Juliana PATKAI         
University Hospital Not yet recruiting
Rennes, France
Contact: Patrick PLADYS, Professor       patrick.pladys@chu-rennes.fr   
Principal Investigator: Patrick PLADYS, Professor         
University Hospital Not yet recruiting
Tours, France
Contact: Elie SALIBA, Professor       elie.saliba@med.univ-tours.fr   
Principal Investigator: Elie SALIBA, Professor         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Study Chair: Véronique GOURNAY, Professor Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01630278     History of Changes
Other Study ID Numbers: 10/6-O
Study First Received: June 11, 2012
Last Updated: September 18, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Nantes University Hospital:
Prematurity
patent ductus arteriosus
ibuprofen

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014