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Plasma Protein Levels and Very Preterm Birth

NCT02007902 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2018-10-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • INSERM CIE1, Dijon, 21000, France

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire de la Réunion

    lead OTHER

Principal Investigators

  • Silvia Iacobelli · CHU de La Réunion -Site du GHSR

  • Sylvain Samperiz, MD · CHU de La Réunion - Hôpital Félix Guyon

Eligibility

Min Age
1 Minute
Max Age
1 Hour
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02007902 on ClinicalTrials.gov