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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN64011614 | Registry Identifier | ISRCTN |
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| Name | Class |
|---|---|
| University Hospital Schleswig-Holstein - Lübeck Campus | UNKNOWN |
| Altona Children's Hospital | OTHER |
| Ruhr University of Bochum | OTHER |
| Vestische Kinder- und Jugendklinik Datteln |
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This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.
80 % of extremely preterm infants with a gestational age of less than 27 completed weeks suffer from severe idiopathic respiratory distress syndrome (IRDS). They are still at high risk of mortality and long term morbidity especially of the lung and the brain. At least death and chronic lung disease (CLD) are related to the need and the duration of mechanical ventilation. Continuous positive airway pressure (CPAP) has been shown to be effective to avoid mechanical ventilation in the treatment of IRDS but it often fails in the most immature infants. Early or prophylactic surfactant application is effective in the treatment of IRDS and is the only causal therapy, but it is usually related to intubation and mechanical ventilation that should be avoided.Therefore to overcome the dilemma between need for mechanical ventilation with surfactant administration on the one hand and surfactant withholding with the use of CPAP on the other hand, a strategy was developed to administer surfactant during spontaneous breathing with CPAP (1). In the proposed prospective randomised controlled trial this strategy shall be compared with the recent gold standard in the therapy of extremely preterm infants with IRDS, that is intubation, mechanical ventilation and surfactant administration. Based on the results of a feasibility (1) study and some clinical observations it is hypothesised that the new approach is superior in avoidance of death and chronic lung disease compared to the recent gold standard.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application |
|
| 1 | Experimental | Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curosurf | Drug | Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival until term without CLD | 13-17 weeks after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Survival until term without CLD, IVH>II°, cystic PVL, ROP with need for surgery | 13-17 weeks after birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Kribs, MD | University of Cologne, Clinic for Paediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Aschaffenburg, Klinik für Kinder- und Jugendmedizin | Aschaffenburg | D-63739 | Germany | |||
| Charité |
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| UNKNOWN |
| Hospital of Leverkusen | UNKNOWN |
| Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl | UNKNOWN |
| Heinrich-Heine University, Duesseldorf | OTHER |
| Klinikum Aschaffenburg-Alzenau | OTHER |
| Asklepios Kliniken Hamburg GmbH | OTHER |
| Klinikum Stuttgart | OTHER |
| DRK Kinderklinik Siegen | UNKNOWN |
| University Hospital, Bonn | OTHER |
| Charite University, Berlin, Germany | OTHER |
| The Clinical Trials Centre Cologne | OTHER |
| German Federal Ministry of Education and Research | OTHER_GOV |
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| Curosurf | Drug | Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application |
|
| Berlin |
| D-13353 |
| Germany |
| Ruhr University of Bochum, Children's Hospital St. Josef Spital | Bochum | D-44791 | Germany |
| University Hospital, Dept. of Neonatology | Bonn | D-53113 | Germany |
| Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl | Cologne | 50735 | Germany |
| University of Cologne, Clinic for Paediatrics | Cologne | D-50937 | Germany |
| Vestische Kinder- und Jugendklinik | Datteln | D-45711 | Germany |
| University Hospital, Clinic for Paediatrics | Düsseldorf | D-40225 | Germany |
| Asklepios Klinik Barmbek | Hamburg | D-22291 | Germany |
| Hospital of Leverkusen, Dept. of Children's Medicine | Leverkusen | D-51375 | Germany |
| University Hospital of Schleswig-Holstein, Campus Lübeck, Dept. of Children's Medicine | Lübeck | D-23538 | Germany |
| DRK Kinderklinik | Siegen | D-57072 | Germany |
| Klinikum Stuttgart, Olgahospital | Stuttgart | D-70196 | Germany |
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C068291 | poractant alfa |
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