Calcium (ca),Phosphorus( P) and 25-hydroxyvitamin D(25OHD)] in Infants Born ≤ 32 PMA Gestational Weeks (GA)
赞助:
Centre of Postgraduate Medical Education
合作者:
信息的提供 (责任方):
Maria Wilinska，Centre of Postgraduate Medical Education
| 追踪信息 | |||
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| 首次提交日期 ICMJE | June 18, 2016 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | January 2016 | ||
| 预计主要完成日期 | December 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Serum 25OHD levels in cord blood in Polish preterm infants[ Time Frame: day of labour ] assessment of 25OH D levels in children deficiency: <10ng/ml, insufficient level: 10-30ng/ml, sufficient level: 30-50ng/ml |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Calcium (ca),Phosphorus( P) and 25-hydroxyvitamin D(25OHD)] in Infants Born ≤ 32 PMA Gestational Weeks (GA) | ||
| 正式标题 ICMJE | The Impact of the Dose of Vitamin D (vitD) on the Metabolism of ca, p and Concentrations of 25OHD, Bone Status and Development of Premature Infants up to 2 Years of Age. Prospective, Randomized, Clinical Study | ||
| 简要概况 | It has not yet been established the optimal dose of vit. D for preterm infants in Poland. It is not known what dose of vit. D will provide the correct concentration of vit. D and the optimal development of the skeleton of the premature. The study will try to determine the optimal supplementation of vitamin D and the supply of Ca and P for normal growth and development of a child born prematurely. In addition, the investigators will evaluate any risk factors for deficiency and excess of vitamin D and the consequences of its deficiency and overdose. Simultaneously the study would make possible the determination of an optimal schedule for controlling the Ca-P levels in the group of the youngest infants born prematurely. In addition, the study will assess the relationship between maternal and newborn vitamin D resources right after birth, and the incidence of vitamin D deficiency in infants born prematurely. Preterm infants will be randomized in 3 groups assigned to different doses of vit. D. The study will investigate the metabolism of calcium, phosphorus, the health of bones and development of the premature babies till the age of 2. |
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| 详细说明 | The participants of the study will be prematures, born ≤32 GA, hospitalized in the Department of Neonatology, in the neonatal intensive care unit. Hospitalized patients who meet the inclusion criteria will be randomized in 3 groups assigned to different doses of vit. D (400, 800 or 1200 units(UNT) of vitamin D). At defined age points of postnatal life, parameters of calcium and phosphorus metabolism and vitamin D level will be tested, along with the health of bones, health status and development. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 3 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Crossover Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Screening |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
200 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 2019 | ||
| 预计主要完成日期 | December 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - gestational age ≤32 weeks at birth - hospitalization in the department no later than at the age of 7 days (for infants born outside the center) - No birth defects or diseases permanently affecting the ability to accept enteral feeding - Anticipated possibility of continuous monitoring of the course of treatment in hospital until discharge - Consent of Parents / legal guardians for the participation in the study. Exclusion criteria - gestational age> 32 weeks at birth - the beginning of hospitalization in the department later than the age of 7 days (for infants born outside the center) - presence of congenital defects or diseases permanently affecting the ability to accept enteral feeding (e.g.oesophageal atresia, anal atresia, congenital umbilical hernia, gastroschisis, syndromes genetically determined) - significant interruption (> 1 week) of the hospitalization in the center - lack of consent of the Parents / legal guardians to participation in the study | ||
| 性别 |
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| 年龄 | 最小年龄：24 Weeks ，最大年龄：32 Weeks | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Poland | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Maria Wilinska，Centre of Postgraduate Medical Education | ||
| 研究赞助商 ICMJE | Centre of Postgraduate Medical Education | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Centre of Postgraduate Medical Education | ||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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