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临床试验/NCT06443515
NCT06443515尚未招募不适用

Evaluation of Respiratory Trends During Blood Transfusions in Newborns.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2024年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
71
试验地点
2
主要终点
Changes in non-invasive peripheral oxygen saturation/fraction of inspired oxygen (SFR) before and after transfusions

研究概览

简要总结

The prevalence of transfusion reactions is between 1 and 11% of transfusions. Most reactions are mild and do not pose a life-threatening risk to the patient. More serious problems may be the only manifestations that lead to suspicion of a transfusion reaction.

Most noninfectious transfusion reactions are immune-mediated. Two main types of reactions can be distinguished: TACO (transfusion associated cardiac overload, which is a cardiogenic pulmonary edema) and TRALI (transfusion related acute lung injury, non-cardiogenic pulmonary edema).

Although TRALI are diagnoses of exclusion, the presence of noncardiogenic pulmonary edema and respiratory problems in the vicinity of blood product transfusions should raise suspicion. Other signs of TRALI are hypotension and tachycardia, while in TACO arterial hypertension with positive water balance can be observed.

According to previous reports, the prevalence of transfusion reactions in the neonatal population is approximately 8%. Factors associated with these reactions are low birth weight and low gestational age. However, diagnostic criteria of respiratory transfusion reactions are not uniform across studies, and often the generic terms "acute lung injury" have been used.

Therefore, the primary objective of this study is to evaluate the respiratory trend during blood transfusions; secondary objectives are the study of risk factors for the development of respiratory worsening and the possible association with complications.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • admitted newborns requiring blood transfusions as per local practice and/or international guidelines

排除标准

  • newborns with major malformations
  • need for palliative care
  • lack of informed consent

结局指标

主要结局

Changes in non-invasive peripheral oxygen saturation/fraction of inspired oxygen (SFR) before and after transfusions

时间窗: within 6 hours before and after the transfusion

non-invasive peripheral oxygen saturation/fraction of inspired oxygen (SFR) will be calculated from clinical charts: data validated by caregivers (primary nurses) will be extracted from the electronic charts to calculate this ratio

Changes in lung ultrasound score (LUS score) before and after transfusions

时间窗: within 6 hours before and after the transfusion

LUS score according to previous publications (Brat et al., 2015) will be calculated

次要结局

  • Changes in ventilatory parameters (mean airway pressure) for patients on nasal continuous positive airway pressure (nCPAP) or mechanical ventilation(within 6 hours before and after the transfusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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