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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small ductus | No Intervention | ||
| Large ductus ibuprofen | Experimental | Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year survival without cerebral palsy | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ASQ (Ages and Stages Questionnaire) score at 2 years | 2 years | |
| Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal) | To compare the outcome between the large and the small ductus groups |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Christophe ROZE, Professor | Nantes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hopsital | Angers | France | ||||
| University Hopsital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33307111 | Derived | 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. | |
| 33301630 |
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| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life |
|
| 2 years |
| Comparison of outcome according to the McNamara stage at surgical ligation | 2 years |
| 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 | France |
| Derived |
| Mitra 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. |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |