Plasma Protein Levels and Very Preterm Birth
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EstatiKonplete
Patwone
Centre Hospitalier Universitaire de la Réunion
Kolaboratè
INSERM CIE1, Dijon, 21000, France
ESÈ KLINIK: NCT02007902
BioSeek: NCT02007902
Mo kle
Abstrè
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.
Dat
| Dènye verifye: | 08/31/2018 |
| Premye Soumèt: | 11/24/2013 |
| Enskripsyon Estimasyon Soumèt: | 12/05/2013 |
| Premye afiche: | 12/10/2013 |
| Dènye Mizajou Soumèt: | 09/27/2018 |
| Dènye Mizajou afiche: | 09/30/2018 |
| Dat aktyèl kòmanse etid la: | 12/31/2013 |
| Dat Estimasyon Prensipal Estimasyon an: | 02/28/2015 |
| Dat estime fini etid la: | 02/28/2015 |
Kondisyon oswa maladi
Very Preterm Infants
Entèvansyon / tretman
Other: Very preterm babies
Faz
-
Gwoup bra
| Bra | Entèvansyon / tretman |
|---|---|
| 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. |
Kritè kalifikasyon yo
| Sèks ki kalifye pou etid | All |
| Metòd echantiyonaj | Non-Probability Sample |
| Aksepte Volontè Healthy | Wi |
| Kritè | 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 |
Rezilta
Mezi Rezilta Prensipal yo
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]
Mezi Rezilta Segondè
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]
