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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Proportion of events managed in accordance with the HAS guidelines for RBC tranfusion in the very preterm infants (< 32 weeks).
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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,...)
结局指标
主要结局
Proportion of events managed in accordance with the HAS guidelines for RBC tranfusion in the very preterm infants (< 32 weeks).
时间窗: during the first month of life
次要结局
- Evolution of the haemoglobin level (Hematocrit)(during the first month of life)
- 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)
- 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)