Red Blood Cell Transfusion in Very Premature Infants and HAS 2014 Guideline (RBCPREM)

Evaluation of the Compliance to HAS 2014 (Haute Autorité de Santé) Guidelines for Red Blood Cells Transfusion in Preterm Infant in a French Neonatal Intensive Care Unit

The indications that motivated the decision to transfuse (or not) were analyzed to verify compliance with HAS recommendations. Medical records from 57 premature infants < 32 weeks hospitalized between 2016 -2017 were retrospectively analysed, especially all the events related to monitoring of hemoglobin level and RBC transfusions during the first month of life. The criteria (postnatal age, rate of haemoglobin, type of breathing assistance, oxygen needing, medullary regeneration) on which rely the decision process in the HAS algorithm for the RBC transfusion were also considered, as well as the final decision actually adopted for each case (transfused/ not transfused). All this made it possible to determine the kappa coefficient for evaluation of agreement with HAS new guidelines in the investigator's medical staff.

Study Overview

Study Type

Observational

Enrollment (Actual)

57

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

    • Picardie
      • Amiens, Picardie, France, 80000
        • Centre Hospitalier Universitaire d'Amiens

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

preterm infant hospitalized in Amiens School hospital (CHU Amiens-Picardie) between October 2016 and April 2017 during the first month of life

Description

Inclusion Criteria:

  • preterm infant hospitalized in Amiens School hospital (CHU Amiens-Picardie) between October 2016 and April 2017 during the first month of life, with allowed access on data recorded in medical files concerning the evolution of clinical characteristics (body weight,…) and the results of laboratory analyses performed during this initial hospital stay.

Exclusion Criteria:

  • less than 25 weeks or more than 32 weeks at birth
  • any hemoglobin dosage during the hospital stay
  • serious congenital malformation
  • known or documented neonatal red blood cell disease (inherited hemolysis, enzymopathy of red blood cell membrane,…)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of events managed in accordance with the HAS guidelines for RBC tranfusion in the very preterm infants (< 32 weeks).
Time Frame: during the first month of life
during the first month of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of the haemoglobin level (Hematocrit)
Time Frame: during the first month of life
from the birth until the day 28, with respect to postnatal age and the gestational age
during the first month of life
volume of blood loss
Time Frame: during the first month of life
during the first month of life
number of transfusion during the first month of life
Time Frame: during the first month of life
during the first month of life
correlation between the number of transfusion and the volume of blood loss
Time Frame: during the first month of life
during the first month of life
Analyses of neonatal morbidity associated with blood transfusion in premature neonates under 32 weeks of pregnancy
Time Frame: during the first month of life
Neonatal morbidity are patent ductus arterious, intraventricular hemorrhage, chronic lung disease, necrotizing enterocolitis, retinopathy of the prematurity, materno-fetal infection and the late-onset infection, and diverse hematological practices
during the first month of life

Collaborators and Investigators

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

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 22, 2018

Primary Completion (ACTUAL)

January 22, 2018

Study Completion (ACTUAL)

January 22, 2018

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

July 23, 2018

First Posted (ACTUAL)

July 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 23, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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