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临床试验/NCT03764813
NCT03764813已完成不适用

Fetal Hemoglobin Levels and Umbilical Cord or Adult Blood RBC Transfusions in Preterm Neonates.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Median Percentage of HbF at 32 Weeks of Post Menstrual Age

研究概览

简要总结

Repeated transfusions have been associated with very poor outcome of preterm infants. Fetal hemoglobin (HbF) and adult Hb (HbA) have different affinity for oxygen. The high level of adult Hb may contribute to exacerbating the oxidative damage responsible for prematurity diseases. The investigators hypothesized that transfusing red blood cells (RBC) obtained from allogeneic cord blood (CB) of healthy full-term babies (which contains almost exclusively HbF) may prevent the non-physiological decrease of HbF in premature neonates, likewise protecting them from oxygen radical diseases. Cord blood transfusion in preterms - CB TRIP - is a monocentric prospective nonrandomized study aimed to monitor HbF levels in preterm neonates receiving RBC transfusions from either umbilical blood of full-term healthy babies (CB-RBC) and/or from adult donors (A-RBC).

详细描述

Preterm neonates enrolled in this study are monitored for the level of HbF on capillary blood samples, from birth to the week 32 of postmenstrual age (PMA). To fulfill the RBC transfusion requirements, RBC concentrates obtained from umbilical blood of full-term healthy babies are utilized, if available; otherwise, RBC concentrates from adult donors are assigned. For every week of PMA, neonates undergo a minimum of three HbF determinations, and the median values are considered.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • preterm neonates born at PMA ≤30 weeks and/or with birth weight ≤1000 g born at the delivery room of Fondazione Policlinico Universitario A. Gemelli candidate to receive one or more RBC unit transfusion.

排除标准

  • One or more of the following criteria Maternal-fetal immunization Hydrops fetalis Major congenital malformations associated or not with genetic syndromes Previous transfusions Hemorrhage at birth Congenital infections (such as infections from TORCH complex) Out-born infants The health care team deems it inappropriate to approach the infant's family for informed consent

结局指标

主要结局

Median Percentage of HbF at 32 Weeks of Post Menstrual Age

时间窗: From study entry to the completion of postmenstrual age of 32 weeks

The HbF level was determined by high-performance liquid chromatography and was expressed as percentage of total Hb, calculated as the sum of fetal and adult Hb, according to the formula: HbF= \[HbF/ (FHbA1 + HbA2 + HbF)\]. HbF.

次要结局

  • Intervals Between Transfusions(From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death)
  • Median Percentage of HbF at Last Assessment(From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death)
  • Post-transfusion Hematocrit (Htc) Change(From enrollment to last HbF assessment occurring at 36 weeks, discharge or death)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

TEOFILI LUCIANA

Medical Director of the UNICATT Cord Blood Bank

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (2)

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