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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00090-45 | Other Identifier | Agence Nationale de Sécurité du Médicament |
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| Name | Class |
|---|---|
| INSERM CIE1, Dijon, 21000, France | UNKNOWN |
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The primary aim of this study is to investigate the relationship between early plasma protein levels and hemodynamics in very preterm infants during postnatal transition. Secondary aims are the following: i) to evaluate maternal and neonatal factors affecting plasma protein level at birth; ii) to evaluate the relationship between plasma protein level and albumin level on the first day of life; iii) to evaluate the association between early hypoproteinemia and neonatal mortality and morbidity in very preterm infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very preterm babies | Observational model: cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of the relationship plasma protein levels - neonatal hemodynamics | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of clinical hemodynamic disturbances defined by arterial hypotension (non-invasive measure of MAP - mmHg - pathological for gestational age) or measured at organ colour doppler, echocardiography or NIRS | about 6 hours after birth |
| Measure | Description | Time Frame |
|---|---|---|
| plasma protein | plasma protein level on cord blood sample depending on maternal and neonatal variables | at 1 second after birth (cord blood sample) |
| Albumin level | At 12 hours after birth |
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Inclusion Criteria:
Exclusion Criteria:
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Very preterm infants with birth at less than 32 weeks of gestational age
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Iacobelli | CHU de La Réunion -Site du GHSR | Principal Investigator |
| Sylvain Samperiz, MD | CHU de La Réunion - Hôpital Félix Guyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hopsitalier Universitaire de La Réunion | Saint-Denis | La Réunion | 97405 | France | ||
| Centre Hospitalier de La Réunion |
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|
| Mortality rate | patients will be followed for the duration of hospital stay, that is an average of 8 weeks |
| Saint-Pierre |
| La Réunion |
| 97448 |
| France |