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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03599167
Acronym
RBCPREM
Enrollment
57
Registered
2018-07-26
Start date
2018-01-22
Completion date
2018-01-22
Last updated
2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Practice Guideline of Erythrocyte Transfusion in Preterm Infant

Keywords

red blood cell transfusion, preterm infant, HAS guideline, transfusion guidelines, kappa agreement test application

Brief summary

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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

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,…)

Design outcomes

Primary

MeasureTime frame
Proportion of events managed in accordance with the HAS guidelines for RBC tranfusion in the very preterm infants (< 32 weeks).during the first month of life

Secondary

MeasureTime frameDescription
Evolution of the haemoglobin level (Hematocrit)during the first month of lifefrom the birth until the day 28, with respect to postnatal age and the gestational age
volume of blood lossduring the first month of life
number of transfusion during the first month of lifeduring the first month of life
correlation between the number of transfusion and the volume of blood lossduring the first month of life
Analyses of neonatal morbidity associated with blood transfusion in premature neonates under 32 weeks of pregnancyduring the first month of lifeNeonatal 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026