- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03599167
Red Blood Cell Transfusion in Very Premature Infants and HAS 2014 Guideline (RBCPREM)
July 23, 2018 updated by: Centre Hospitalier Universitaire, Amiens
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
Status
Completed
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
-
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Picardie
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Amiens, Picardie, France, 80000
- Centre Hospitalier Universitaire d'Amiens
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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
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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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI01-MME-BESSARION
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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-
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-
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