Plasma Protein Levels and Very Preterm Birth
Aðeins skráðir notendur geta þýtt greinar
Skráðu þig / skráðu þig
Krækjan er vistuð á klemmuspjaldið
StaðaLokið
Styrktaraðilar
Centre Hospitalier Universitaire de la Réunion
Samstarfsmenn
INSERM CIE1, Dijon, 21000, France
KLÍNÍSK RANNSÓKN: NCT02007902
BioSeek: NCT02007902
Lykilorð
Útdráttur
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.
Dagsetningar
| Síðast staðfest: | 08/31/2018 |
| Fyrst lagt fram: | 11/24/2013 |
| Áætluð skráning lögð fram: | 12/05/2013 |
| Fyrst sent: | 12/10/2013 |
| Síðasta uppfærsla lögð fram: | 09/27/2018 |
| Síðasta uppfærsla sett upp: | 09/30/2018 |
| Raunverulegur upphafsdagur náms: | 12/31/2013 |
| Áætlaður aðallokunardagur: | 02/28/2015 |
| Áætlaður dagsetningu rannsóknar: | 02/28/2015 |
Ástand eða sjúkdómur
Very Preterm Infants
Íhlutun / meðferð
Other: Very preterm babies
Stig
-
Armhópar
| Armur | Íhlutun / meðferð |
|---|---|
| Very preterm babies Observational model: cohort | Other: Very preterm babies Patient inclusion at birth
Total plasma protein values measurement on cord blood sample at birth
Hemodynamic evaluation at 6 hours after birth with colour doppler echocardiography and organ blood flow colour doppler
Total plasma protein and albumin values measurement on plasma sample at 12 hours after birth
Blood pressure, heart rate, O2 saturation, capillary refill time, rSO2 [regional (cerebral and somatic) tissue oxygenation by NIRS - near infrared spectroscopy] will be monitored over 24 hours after birth. |
Hæfniskröfur
| Kyn sem eru hæf til náms | All |
| Sýnatökuaðferð | Non-Probability Sample |
| Tekur við heilbrigðum sjálfboðaliðum | Já |
| Viðmið | Inclusion Criteria: - Parents written informed consent - Birth at less than 32 weeks of gestational age - Birth in a III level delivery facility at Reunion Island Exclusion Criteria: - Major congenital abnormalities |
Útkoma
Aðal niðurstöður ráðstafanir
1. 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]
Aðgerðir vegna aukaatriða
1. plasma protein [at 1 second after birth (cord blood sample)]
plasma protein level on cord blood sample depending on maternal and neonatal variables
2. Albumin level [At 12 hours after birth]
3. Mortality rate [patients will be followed for the duration of hospital stay, that is an average of 8 weeks]
