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

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01630278
• Collaborator: (none)
• Enrollment: 363
• Locations: 11
• Arms: 3
• Actual Duration (Months): 87
• Patients Per Site: 33
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus	Drug: Ibuprofen; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 363 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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)
• Actual Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 2-year survival without cerebral palsy [2 years]

Secondary Outcome Measures

1. ASQ (Ages and Stages Questionnaire) score at 2 years [2 years]

2. Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal) [2 years]

   To compare the outcome between the large and the small ductus groups

3. Comparison of outcome according to the McNamara stage at surgical ligation [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 28 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Gestational less than 28 weeks

• Postnatal age less than 12 hours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hopsital	Angers		France
2	University Hopsital	Bordeaux		France
3	University Hospital	Créteil		France
4	University Hospital	Grenoble		France
5	University Hospital	Lille		France
6	University Hospital	Marseille		France
7	Univesity Hospital	Montpellier		France
8	University Hospital	Nantes		France
9	University Hospital (AP-HP Groupe hospitalier)	Paris		France
10	University Hospital	Rennes		France
11	University Hospital	Tours		France

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Study Chair: Jean-Christophe ROZE, Professor, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT01630278
• Other Study ID Numbers: BRD/10/06-O
• First Posted: Jun 28, 2012
• Last Update Posted: Jul 8, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by Nantes University Hospital: Prematurity; patent ductus arteriosus; ibuprofen
• Additional relevant MeSH terms: Ductus Arteriosus, Patent; Ibuprofen

Study Results

No Results Posted as of Jul 8, 2019