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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012817-23 | Registry Identifier | EUDRACT |
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| Name | Class |
|---|---|
| ARAIRLOR | UNKNOWN |
| Chiesi Farmaceutici S.p.A. | INDUSTRY |
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Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of BPD are not always effective, or related to major side effects. The physiopathological factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the use of an exogenous surfactant in neonates presenting with pulmonary disease requiring mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation and thus promote pulmonary healing and growth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surfactant instillation | Experimental | 2.5 ml/kg of Surfactant will be instilled in the trachea |
|
| Placebo instillation | Placebo Comparator | 2.5 ml/kg of Air will be instilled in the trachea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curosurf | Drug | 2.5 ml/kg instilled in the trachea |
| |
| Measure | Description | Time Frame |
|---|---|---|
| duration of assisted ventilation | we aim to demonstrate a significant reduction in the duration of assisted ventilation in children presenting with severe respiratory distress at 14+/-2 days of life. | days |
| Measure | Description | Time Frame |
|---|---|---|
| to reduce the incidence of BPD | 36 weeks post conceptional age | |
| to improve the inflammatory status of the lung and to restore its capacities for healing and growth | one month | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Michel HASCOET, MD | Maternite Regionale Universitaire NANCY | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Hopital Nord | Amiens | 80054 | France | |||
| CHU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26928567 | Result | Hascoet JM, Picaud JC, Ligi I, Blanc T, Moreau F, Pinturier MF, Zupan V, Guilhoto I, Hamon IR, Alexandre C, Bouissou A, Storme L, Patkai J, Pomedio M, Rouabah M, Coletto L, Vieux R. Late Surfactant Administration in Very Preterm Neonates With Prolonged Respiratory Distress and Pulmonary Outcome at 1 Year of Age: A Randomized Clinical Trial. JAMA Pediatr. 2016 Apr;170(4):365-72. doi: 10.1001/jamapediatrics.2015.4617. | |
| 29193276 |
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| Air |
| Other |
2.5ml/kg of Air will be instilled in the trachea |
|
| to improve development in stature and weight, psychomotor development, and to reduce respiratory sequelae leading to re-hospitalisation |
| 2 years of age |
| to improve height development, psychomotor development and respiratory function | 7 years of age |
| Angers |
| 49033 |
| France |
| Centre Hospitalier | Arras | 62000 | France |
| CHU Hopital Clemenceau | Caen | 14033 | France |
| CHU hopital d'enfants | Dijon | 21079 | France |
| Centre Hospitalier | Lens | 62037 | France |
| CHU Hopital Jeanne de Flandre | Lille | 59037 | France |
| CHU Hopital de la Croix Rousse | Lyon | 69004 | France |
| APHM hopital de la conception | Marseille | 13385 | France |
| CHI Andre Gregoire | Montreuil | 93105 | France |
| Maternite Regionale Universitaire | Nancy | 54042 | France |
| AP-HP Hopital Port Royal | Paris | 75179 | France |
| CHU Hopital Gatien de Clocheville | Tours | 37044 | France |
| Result |
| Hascoet JM, Picaud JC, Ligi I, Blanc T, Daoud P, Zupan V, Moreau F, Guilhoto I, Rouabah M, Alexandre C, Saliba E, Storme L, Patkai J, Pomedio M, Hamon I. Review shows that using surfactant a number of times or as a vehicle for budesonide may reduce the risk of bronchopulmonary dysplasia. Acta Paediatr. 2018 Jul;107(7):1140-1144. doi: 10.1111/apa.14171. Epub 2017 Dec 22. |
| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| D012127 | Respiratory Distress Syndrome, Newborn |
| D001997 | Bronchopulmonary Dysplasia |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C068291 | poractant alfa |
| D000388 | Air |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
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