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临床试验/NCT05949788
NCT05949788已完成不适用

Analyses of Anemia Risk Factors and Prognosis in VLBW Infants.

Shenzhen Bao'an Maternal and Child Health Hospital1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
146
试验地点
1
主要终点
The Incidence of Early Onset Sepsis in VLBW Infants With AOP.

研究概览

简要总结

To study and analyze the association of the severity of anemia with neonatal morbidity and the risk factors of anemia in ealry life (less than 3 days of life) among the very low birth weight (VLBW) infants.

详细描述

The rescue treatment of very low birth weight (VLBW) infants is the main task of our neonatal intensive care unit (NICU) is this era. Anemia of prematurity (AOP) is one of the most common complication of these infants, which can affect their growth, intelligence, behavior, immunity and hemodynamics, and even endanger their lives in severe situation. It is of great significance to investigate the association of the severity of anemia with neonatal morbidity and the risk factors of anemia in ealry life for improving the prognosis of these infants.

Patient Registry procedures: First, the list of VLBW infants was obtained through medical record search, and sent to the principal investigator (PI) at each center when an infant was eligible for enrollment. Second, patients are included in this study according to the exclusion criteria by PI. Finally, the PI at each center will be responsible for the accuracy,completeness or representativeness of medical records, registry forms,data collection.

Statistical analysis

The two groups were compared by a Χ2-test for categorical variables, Mann-Whitney U Test were used when reporting medians.A P value of <0.05 was considered statistically significant.

研究设计

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

入排标准

年龄范围
— 至 4 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants less than 32 weeks of gestational age and birth weight below 1500 g and who survive to NICU are eligible for the trial.
  • Anemia was defined as a central venous hemoglobin harvested in the first 3 days of life less than two standard deviations below the mean for postnatal age.

排除标准

  • Asphyxia (arterial pH <7.0, fifth minute Apgar score <3),
  • Twin-to twin-transfusion syndrome,
  • Discordant twins (difference in birth weight >20%),
  • Major congenital anomalies or chromosomal anomalies,
  • Disagree of parents.

结局指标

主要结局

The Incidence of Early Onset Sepsis in VLBW Infants With AOP.

时间窗: through study completion, an average of 6 months

The incidence of early onset sepsis in very low birth weigh (VLBW) infants with anemia of prematurity (AOP)

次要结局

  • The Maternal Hb Levels Before Birth Among VLBW Infants With AOP.(Through study completion, an average of 6 months)
  • Mortality and Morbidity Among Extremely Preterm Infants With Anemia of Prematurity (AOP)(Through study completion, an average of 6 months)

研究者

发起方
Shenzhen Bao'an Maternal and Child Health Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun Luo

Principal Investigator

Shenzhen Bao'an Maternal and Child Health Hospital

研究点 (1)

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