Plasma Protein Levels and Very Preterm Birth

Study Overview
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Brief Summary
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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.

Official Title
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Early Plasma Protein Levels and Neonatal Hemodynamics: a Prospective Evaluation in Very Preterm Infants

Conditions
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Very Preterm Infants

Intervention / Treatment
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* Other: Evaluation of the relationship plasma protein levels - neonatal hemodynamics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 1 Hour

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Very preterm babies<br>Observational model: cohort | Other: Evaluation of the relationship plasma protein levels - neonatal hemodynamics<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Mortality rate |  | patients will be followed for the duration of hospital stay, that is an average of 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Preterm baby, Total plasma protein, Albumin, Hemodynamic disturbances, Perfusion, Near Infra Red Spectroscopy (NIRS)