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

Completed

• Conditions: Practice Guideline of Erythrocyte Transfusion in Preterm Infant

• Registration Number: NCT03599167
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-22
• Primary Completion: 2018-01-22
• Study Completion: 2018-01-22
• Status Verified: 2018-07
• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-23
• Last Update Submitted: 2018-07-23
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evolution of the haemoglobin level (Hematocrit)	during the first month of life	from the birth until the day 28, with respect to postnatal age and the gestational age
correlation between the number of transfusion and the volume of blood loss	during the first month of life
Analyses of neonatal morbidity associated with blood transfusion in premature neonates under 32 weeks of pregnancy	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
number of transfusion during the first month of life	during the first month of life
volume of blood loss	during the first month of life

Trial Locations

Locations (1)

Centre Hospitalier Universitaire d'Amiens; 🇫🇷 Amiens, Picardie, France