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