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临床试验/NCT03779776
NCT03779776已完成不适用

The Department of Neonatology, Zhengzhou Children's Hospital

Zhengzhou Children's Hospital, China1 个研究点 分布在 1 个国家目标入组 676 人开始时间: 2018年7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
676
试验地点
1
主要终点
rates of bronchopulmonary dysplasia

研究概览

简要总结

Bronchopulmonary dysplasia (BPD) is the most prevalent longterm morbidity among surviving extremely preterm infants and has a multifactorial etiology. BPD is associated with later risk of reactive airways disease, such as asthma, post neonatal mortality and adverse neurodevelopmental outcomes.Retinopathy of prematurity (ROP) is a common retinal neovascular disorder and a major cause of vision impairment or blindness in preterm infants, even with aggressed current standard care.Accumulating epidemiologic evidence suggests that vitamin D (VD) deficiency or insufficiency is associated with respiratory disease and metabolic bone disease in premature children.Vitamin A (VA) plays an integral part in lung growth and differentiation. VA is an essential micronutrient for normal visual function.

Our prospective double-blinded randomized controlled trial will include infants born at <32 weeks' gestation and admitted to six tertiary NICUs in China. Infants in the intervention (vitamin AD drops) group will receive the daily dose VA at 1500 IU/day with VD 500 IU/day, added to their enteral feeds in drop form as soon as minimal feeding was introduced, and continued to 28 days or discharge. Infants in the control group will receive an equivalent volume of a placebo solution. Following informed consent, enrolled infants will be randomly allocated to the control or VAD group. The primary outcome is bronchopulmonary dysplasia (BPD) , ROP, or metabolic bone disease and the secondary outcomes are mortality; NEC ≥ stage 2; ; late-onset sepsis; weight gain, change in weight, increase in length, increase in head circumference; time to full enteral feeds; and number and type of critical incident reports.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
1 Hour 至 96 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • gestational age<32 weeks,
  • <96 hours of age

排除标准

  • genetic metabolic diseases;
  • congenital major abnormalities;
  • congenital non-bacterial infection with overt signs at birth;
  • terminal stage of illness (pH < 7.0 or hypoxia with bradycardia>2 h);
  • ≥ grade III intracranial hemorrhage;
  • lacking parental consent.

结局指标

主要结局

rates of bronchopulmonary dysplasia

时间窗: 1 year

The rates of bronchopulmonary dysplasia with early vitamin AD supplementation

rates of retinopathy of prematurity

时间窗: 1 year

The rates of retinopathy of prematurity with early vitamin AD supplementation

Metaboloc bone disease

时间窗: 1 year

The rates of Metaboloc bone disease of prematurity with early vitamin AD supplementation

次要结局

  • rates of Necrotizing enterocolitis(1 year)

研究者

发起方
Zhengzhou Children's Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huiqing Sun

Vice Director of Neonatology department

Zhengzhou Children's Hospital, China

研究点 (1)

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