The Effect of Maternal and Neonatal Vitamin D Levels on Respiratory Distress Syndrome in Preterm Infants
2014年1月6日 更新者:Merih Cetinkaya、Kanuni Sultan Suleyman Training and Research Hospital
Respiratory distress syndrome (RDS) of the newborn, also called as hyaline membrane disease, is the most common cause of respiratory distress in premature infants, correlating with structural and functional lung immaturity.
The pathophysiology of RDS is complex.
Immature type II alveolar cells produce less surfactant that causes an increase in alveolar surface tension and a decrease in compliance.
This resultant atelectasis lead to pulmonary vascular constriction, hypoperfusion, and lung tissue ischemia.
RDS and prolonged ventilation and associated systemic/lung injury may also contribute to long term oxygen dependency and may result in bronchopulmonary dysplasia (BPD).
Vitamin D is a fat-soluble steroid hormone that primarily contributes to the maintenance of normal calcium homeostasis and skeletal mineralization.
In addition to its classical role in bone metabolism, vitamin D deficiency has been associated with impaired pulmonary function, increased incidence of viral and bacterial infections and inflammatory lung diseases.
Although exact mechanisms are not fully understood, vitamin D appears to impact on a variety of inflammatory and structural cells within the lung including macrophages, lymphocytes and epithelial cells.
To our best of knowledge, no study has evaluated the effect of vitamin D levels on the severity and presence of RDS in preterm infants.
Therefore, the aim of this study is to evaluate the possible role of maternal/neonatal vitamin D levels on RDS development in preterm infants.
We also aim to determine the possible association between maternal/neonatal vitamin D levels and the incidence of BPD and other neonatal morbidities.
研究概览
地位
完全的
条件
详细说明
Preterm infants with respiratory distress who are <37 weeks of gestational age and will be admitted to Neonatal Intensive Care Unit of Kanuni Sultan Suleyman Training and Research Hospital will be included in this prospective study.
Blood for neonatal and maternal vitamin D levels will be obtained from all infants and their mothers at the time of hospital admission.
The infants will be evaluated for RDS and surfactant requirement.
If they have RDS and need of mechanical ventilation, they will be intubated and given surfactant, if necessary.
The maternal and neonatal demographics of infants will be recorded.
Infants will also be followed up in terms of other morbidities including patent ductus arteriosus, necrotizing enterocolitis, retinopathy of prematurity, and especially BPD.
Then infants will be divided into three groups according to maternal/neonatal vitamin D levels (mild, moderate and severe vitamin D deficiency) and group comparisons will be performed Plasmas after separated and stored at -80 C. Levels of 25-OHD will be determined using Shimadzu LC-20AT model High Performance Liquid Chromatography (HPLC) system.
Data will be analyzed using SPSS software and appropriate statistical analyses will be performed.
研究类型
观察性的
注册 (实际的)
100
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
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Stanbul、火鸡、34052
- Kanuni Sultan Suleyman Training and Research Hospital
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 3天 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Premature infants admitted to neonatal intesive care unit with the diagnosis of respiratory distress syndrome (RDS) will constitute the RDS group, whereas preterm infants without RDS will constitute the non-RDS group
描述
Inclusion Criteria:
- Preterm infants <37 weeks of gestational age and are admitted to Neonatal Intensive Care Unit of Kanuni Sultan Suleyman Training and Research Hospital
- Preterm infants with clinical and laboratory findings of RDS
Exclusion Criteria:
- presence of maternal clinical and/or histological chorioamnionitis,
- presence of premature rupture of membranes (PROM),
- refusal of parental consent,
- lack of laboratory data,
- major congenital abnormalities
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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RDS group, non-RDS group
RDS group; infants with clinical, radiological and laboratory findings of RDS non-RDS group; infants without clinical, radiological and laboratory findings of RDS
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
development of respiratory distress in infants according to vitamin D levels
大体时间:1 year
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A total of 100 preterm infants will be included and vitamin D levels will be compared between those with and without respiratory distress syndrome
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1 year
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次要结果测量
结果测量 |
大体时间 |
---|---|
presence of vitamin D deficiency and bronchopulmonary dysplasia
大体时间:1 year
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1 year
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其他结果措施
结果测量 |
大体时间 |
---|---|
development of prematurity morbidities
大体时间:1year
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1year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Merih Cetinkaya, MD, PhD、Kanuni Sultan Suleyman Training and Research Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Parekh D, Thickett DR, Turner AM. Vitamin D deficiency and acute lung injury. Inflamm Allergy Drug Targets. 2013 Aug;12(4):253-61. doi: 10.2174/18715281113129990049.
- Gupta A, Bush A, Hawrylowicz C, Saglani S. Vitamin D and asthma in children. Paediatr Respir Rev. 2012 Dec;13(4):236-43; quiz 243. doi: 10.1016/j.prrv.2011.07.003. Epub 2011 Sep 1.
- Bener A, Ehlayel MS, Tulic MK, Hamid Q. Vitamin D deficiency as a strong predictor of asthma in children. Int Arch Allergy Immunol. 2012;157(2):168-75. doi: 10.1159/000323941. Epub 2011 Oct 6.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年12月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2013年12月27日
首先提交符合 QC 标准的
2013年12月30日
首次发布 (估计)
2013年12月31日
研究记录更新
最后更新发布 (估计)
2014年1月7日
上次提交的符合 QC 标准的更新
2014年1月6日
最后验证
2014年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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