Clinical trial NCT03599167: Red Blood Cell Transfusion in Very Premature Infants and HAS 2014 Guideline
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Practice Guideline of Erythrocyte Transfusion in Preterm Infant
Keywords: red blood cell transfusion
preterm infant
HAS guideline
transfusion guidelines
kappa agreement test application
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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,...)

Primary outcomes:
measure: Proportion of events managed in accordance with the HAS guidelines for RBC tranfusion in the very preterm infants (< 32 weeks).
timeFrame: during the first month of life
Secondary outcomes:
measure: Evolution of the haemoglobin level (Hematocrit)
timeFrame: during the first month of life
measure: volume of blood loss
timeFrame: during the first month of life
measure: number of transfusion during the first month of life
timeFrame: during the first month of life
measure: correlation between the number of transfusion and the volume of blood loss
timeFrame: during the first month of life
measure: Analyses of neonatal morbidity associated with blood transfusion in premature neonates under 32 weeks of pregnancy
timeFrame: during the first month of life
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens
state: Picardie
Study officials:
References: