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| ID | Type | Description | Link |
|---|---|---|---|
| 0203222 |
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Prevention trial of nosocomial infections in neutropenic prematures with G-CSF
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| groupe filigrastin | Active Comparator |
| |
| groupe placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Drug | The G-CSF (filigrastin) will be administered by intravenous way with the amount of 10 µg/kg/day during 3 days . The infusion will last from 20 to 40 minutes according to weight of the child and the product will be diluted in dextrose 5%. |
| Measure | Description | Time Frame |
|---|---|---|
| survival without infection at 4 weeks after treatment | one month |
| Measure | Description | Time Frame |
|---|---|---|
| survival free of infection at 2 weeks after treatment,mortality, increase of neutrophile, number of septic event, incidence of chronic lung disease, necrotizing enterocolitis, cerebral us abnormalities, retinopathy , duration of hospitalisation stay | one month |
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Inclusion Criteria:
< 33 weeks GA neutropenic during at least 24 hours in the first 3 weeks of life and not infected at time of inclusion < 35 if birth weight < 1500 g
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| Name | Affiliation | Role |
|---|---|---|
| Jean Messer, MD | Hopitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xavier Hernandorena | Bayonne | France | ||||
| Alain Menget |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19467544 | Derived | Kuhn P, Messer J, Paupe A, Espagne S, Kacet N, Mouchnino G, Klosowski S, Krim G, Lescure S, Le Bouedec S, Meyer P, Astruc D. A multicenter, randomized, placebo-controlled trial of prophylactic recombinant granulocyte-colony stimulating factor in preterm neonates with neutropenia. J Pediatr. 2009 Sep;155(3):324-30.e1. doi: 10.1016/j.jpeds.2009.03.019. Epub 2009 May 24. |
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| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D047928 | Premature Birth |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| dextrose 5% | Drug | The placebo (dextrose 5% ) will be injected by intravenous way with the amount of 0.66 ml/kg during 3 days consecutive. The infusion will last from 20 to 40 minutes. |
|
| Besançon |
| France |
| Jean-Louis Demarquez | Bordeaux | France |
| Bernard Guillois | Caen | France |
| Marie Thieuleux | Calais | France |
| André Labbe | Clermont-Ferrand | France |
| Jean-Bernard Gouyon | Dijon | France |
| Pierre Andrini | Grenoble | France |
| Jean Messer | Strasbourg | France |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |