Plasma Protein Levels and Very Preterm Birth (ProHémie)

September 28, 2018 updated by: Centre Hospitalier Universitaire de la Réunion

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • La Réunion
      • Saint Denis, La Réunion, France, 97405
        • Centre Hopsitalier Universitaire de La Réunion
      • Saint Pierre, La Réunion, France, 97448
        • Centre hospitalier de la Réunion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 hour (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Very preterm infants with birth at less than 32 weeks of gestational age

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Very preterm babies
Observational model: cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: about 6 hours after birth
about 6 hours after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 1 second after birth (cord blood sample)
Albumin level
Time Frame: At 12 hours after birth
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
patients will be followed for the duration of hospital stay, that is an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Collaborators

INSERM CIE1, Dijon, 21000, France

Investigators

  • Principal Investigator: Silvia Iacobelli, CHU de La Réunion -Site du GHSR
  • Principal Investigator: Sylvain Samperiz, MD, Chu de La Reunion - Hopital Felix Guyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

November 25, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Actual)

October 1, 2018

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/CHU/02
  • 2013-A00090-45 (Other Identifier: Agence Nationale de Sécurité du Médicament)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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