Plasma Protein Levels and Very Preterm Birth

Overview

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.

Full Title of Study: “Early Plasma Protein Levels and Neonatal Hemodynamics: a Prospective Evaluation in Very Preterm Infants”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2015

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.

Arms, Groups and Cohorts

  • Very preterm babies
    • Observational model: cohort

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: about 6 hours after birth

Secondary Measures

  • plasma protein
    • Time Frame: at 1 second after birth (cord blood sample)
    • plasma protein level on cord blood sample depending on maternal and neonatal variables
  • Albumin level
    • Time Frame: At 12 hours after birth
  • Mortality rate
    • Time Frame: patients will be followed for the duration of hospital stay, that is an average of 8 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Minute

Maximum Age: 1 Hour

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de la Réunion
  • Collaborator
    • INSERM CIE1, Dijon, 21000, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Silvia Iacobelli, Principal Investigator, CHU de La Réunion -Site du GHSR
    • Sylvain Samperiz, MD, Principal Investigator, CHU de La Réunion – Hôpital Félix Guyon

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