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临床试验/NCT03618394
NCT03618394已完成不适用

Early Bone Turnover Markers in Relation to Parenteral Nutrition Regimens

Iaso Maternity Hospital, Athens, Greece1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2015年4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
66
试验地点
1
主要终点
change in plasma calcium and osteocalcin levels

研究概览

简要总结

Evaluation of changes in biochemical markers of bone metabolism. Fat profile. Evaluation of the overall body development. Assessment of parenteral nutrition protocols.

详细描述

Osteopenia is very common in premature infants, particularly in preterm infants born at extremely low birth weight This is probably related to inadequate calcium and phosphorus intake, which is considerably less than the accretion of these minerals during the last trimester of pregnancy In addition, severe morbidity during the neonatal period (e.g. bronchopulmonary dysplasia [BPD]), chronic drug therapy (e.g. diuretics and systemic steroids), the need for total parenteral nutrition and prolonged immobility increase the risk of bone demineralization.

Total parenteral nutrition is associated with osteopenia in preterm infants. Insufficient calcium and phosphate are likely causes; aluminum contamination is another possible contributing factor as this adversely affects bone formation and mineralization.

The DHA+ARA-supplemented formulas supported normal growth and bone mineralization in premature infants who were born at <33 wk gestation. Smof lipid emulsion has a high density of this fatty acids, while Intra lipid does not contain any traces of DHA. Evidence has shown that long-chain polyunsaturated fatty acids (LCPUFA), especially the ω-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are beneficial for bone health and turnover.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Day 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • gestational age <32 weeks
  • birth weight <1500g (VLBW infants)
  • in need of Parenteral Nutrition support

排除标准

  • >32 weeks of gestation
  • chromosomal or other abnormalities
  • parenteral nutrition <80% of calorie/fluid needs
  • primary liver disease

结局指标

主要结局

change in plasma calcium and osteocalcin levels

时间窗: 20 days

Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life

次要结局

  • cange in plasma OPG levels(20 days)
  • change in plasma DHA, EPA levels(20 days)

研究者

发起方
Iaso Maternity Hospital, Athens, Greece
申办方类型
Other
责任方
Principal Investigator
主要研究者

Panos Papandreou

Clinical Pharmacist, PharmD

Iaso Maternity Hospital, Athens, Greece

研究点 (1)

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