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临床试验/NCT05944055
NCT05944055招募中不适用

Is 25OHD Overdoses Before 36 Weeks Corrected Age an Independant Risk Factor of Bronchopulmonary Dysplasia or Death ?

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
173
试验地点
1
主要终点
Bronchopulmonary dysplasia or death

研究概览

简要总结

Several studies have demonstrated that vitamin D deficiency at birth is a risk factor of bronchopulmonary dysplasia. However, in an animal model of bronchopulmonary dysplasia vitamin D overdose has also been associated with an increased mortality and an increased lung injury. Such vitamin D overdose has been frequently reported in hospitalized neonates receiving the current supplementation.

The hypothesis is that vitamin D overdose is an independent risk factor of bronchopulmonary dysplasia or death among infants born below 31 weeks gestational age excluding infants with vitamin D deficiency.

This retrospective cohort study will include all infants born before 31 weeks of gestation (WG), who were hospitalized in a tertiary neonatal intensive care unit (NICU) during at least 10 days, for who at least one 25OH vitamin D determination was performed before 36 WG corrected age and whose parents are not opposed to the study. A descriptive analysis of the cohort depending on the occurrence of vitamin D overdose will be performed. A multivariate analysis will determine if vitamin D overdose is an independent risk factor of bronchopulmonary dysplasia or death among preterm infants, adjusting on the covariates known to be associated with bronchopulmonary dysplasia.

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
23 Weeks 至 31 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria * :
  • Infant born before 31 weeks of gestation.
  • hospitalized in the NICU during at least 10 days
  • with at least a 25OH-D determination available before 36 weeks corrected age

排除标准

  • Infant with at least a 25OH-D below 50 nmol/L

结局指标

主要结局

Bronchopulmonary dysplasia or death

时间窗: The outcome will be assessed at 36 weeks corrected age.

Bronchopulmonary dysplasia is defined as any respiratory support or oxygen requirement at 36 weeks corrected age.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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