Patent Ductus ArteriosusPhase 3TRIOCAPINCT01630278
Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)
A Phase 3 study testing Ibuprofen in people with Patent Ductus Arteriosus, run by Nantes University Hospital at 11 sites in France.
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. Read more about this study
- Who is it for?
- Ages Up to 28 weeks
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 363 participants
- Where
- 11 sitesFrance
- Study dates
- Mar 2012to Jun 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational less than 28 weeks
- Postnatal age less than 12 hours
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
University Hopsital
Angers
University Hopsital
Bordeaux
University Hospital
Créteil
University Hospital
Grenoble
University Hospital
Lille
University Hospital
Marseille
Univesity Hospital
Montpellier
University Hospital
Nantes
University Hospital (AP-HP Groupe hospitalier)
Paris
University Hospital
Rennes
University Hospital
Tours
About this study
Official title: Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)
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
- Being tested
- Ibuprofen, Placebo
- Keywords
- Prematurity, patent ductus arteriosus, ibuprofen
- Medical subject headings
- Ductus Arteriosus, Patent, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
PlaceboDrug
Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life
| Study group | Role | What they receive |
|---|---|---|
| Small ductus | No intervention | Not described |
| Large ductus ibuprofen | Experimental | Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life Receives: Drug: Ibuprofen |
| Large ductus placebo | Placebo comparator | Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year survival without cerebral palsy
Measured: 2 years
Secondary outcomes (3)
ASQ (Ages and Stages Questionnaire) score at 2 years
Measured: 2 years
Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal)
To compare the outcome between the large and the small ductus groups
Measured: 2 years
Comparison of outcome according to the McNamara stage at surgical ligation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe ROZE, Professor, Study chair, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630278
- Sponsor's protocol ID
- BRD/10/06-O
- Acronym
- TRIOCAPI
- Status last verified
- Jul 2019
- First submitted
- 11 Jun 2012
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roze JC, Cambonie G, Le Thuaut A, Debillon T, Ligi I, Gascoin G, Patkai J, Beuchee A, Favrais G, Flamant C, Durrmeyer X, Clyman R. Effect of Early Targeted Treatment of Ductus Arteriosus with Ibuprofen on Survival Without Cerebral Palsy at 2 Years in Infants with Extreme Prematurity: A Randomized Clinical Trial. J Pediatr. 2021 Jun;233:33-42.e2. doi: 10.1016/j.jpeds.2020.12.008. Epub 2020 Dec 9.
PubMed 33307111Mitra S, Scrivens A, von Kursell AM, Disher T. Early treatment versus expectant management of hemodynamically significant patent ductus arteriosus for preterm infants. Cochrane Database Syst Rev. 2020 Dec 10;12(12):CD013278. doi: 10.1002/14651858.CD013278.pub2.
PubMed 33301630
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)
- ClinicalTrials.gov ID
- NCT01630278
- Acronym / sponsor ID
- TRIOCAPI / BRD/10/06-O
- Conditions
- Patent Ductus Arteriosus
- Keywords
- Prematurity, patent ductus arteriosus, ibuprofen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Small ductus | No intervention | – |
| Large ductus ibuprofen | Experimental | Drug: IbuprofenVery premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life |
| Large ductus placebo | Placebo comparator | Drug: PlaceboVery premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life |
Who may qualify
- Ages
- Up to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational less than 28 weeks
- Postnatal age less than 12 hours
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenVery premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life | Drug | Large ductus ibuprofen |
| PlaceboVery premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life | Drug | Large ductus placebo |
Primary outcome
2-year survival without cerebral palsy
Time frame: 2 years
3 secondary outcomes
ASQ (Ages and Stages Questionnaire) score at 2 years
Time frame: 2 years
Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal)
Time frame: 2 years
Comparison of outcome according to the McNamara stage at surgical ligation
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 33307111Roze JC, Cambonie G, Le Thuaut A, Debillon T, Ligi I, Gascoin G, Patkai J, Beuchee A, Favrais G, Flamant C, Durrmeyer X, Clyman R. Effect of Early Targeted Treatment of Ductus Arteriosus with Ibuprofen on Survival Without Cerebral Palsy at 2 Years in Infants with Extreme Prematurity: A Randomized Clinical Trial. J Pediatr. 2021 Jun;233:33-42.e2. doi: 10.1016/j.jpeds.2020.12.008. Epub 2020 Dec 9.
- Derived from this study: PubMed 33301630Mitra S, Scrivens A, von Kursell AM, Disher T. Early treatment versus expectant management of hemodynamically significant patent ductus arteriosus for preterm infants. Cochrane Database Syst Rev. 2020 Dec 10;12(12):CD013278. doi: 10.1002/14651858.CD013278.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Christophe ROZE, Professor study chair
Nantes University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen in people with Patent Ductus Arteriosus, run by Nantes University Hospital at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year survival without cerebral palsy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01630278, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.