NCT02007902

Plasma Protein Levels and Very Preterm Birth

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: Centre Hospitalier Universitaire de la Réunion · Academic / Other
• Sex: All
• Age: 1 Minute – 1 Hour
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Very Preterm Infants

Interventions

Type	Name	Description
OTHER	Evaluation of the relationship plasma protein levels - neonatal hemodynamics	* 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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-12-11
• Last updated: 2018-10-01

Locations

2 sites across 1 country: France