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临床试验/CTRI/2024/06/068731
CTRI/2024/06/068731尚未招募不适用

Proportion of very preterm neonates with abnormal serum zinc levels: A Prospective observational study.

KIMSHealth1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年6月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
72
试验地点
1
主要终点
Proportion of very preterm with low zinc levels

研究概览

简要总结

Zinc is the 2nd most abundant active trace element in human body after iron. It is essential in growth and tissue differentiation via gene transcription, metabolism of macronutrients and hormonal activity. Preterm infants are at high risk for zinc deficiency due to low body stores, increased renal and intestinal losses, low intake and high demand due to high growth velocity. Zinc deficiency in preterm is associated with stunted growth, increased risk of infections, skin rash and possibly poor neurodevelopment. There are limited studies on serum zinc levels in preterm babies in early postnatal life and adequacy of current zinc supplementation policy in very preterm babies is largely unknown. Relation between zinc deficiency and morbidities like NEC, MBD, ROP, BPD, infections and brain injury is not well established.

This study is a prospective observational study in preterm less than or equal to 32 weeks, includes collection of data at defined timepoints. Serum zinc values which are measured at least after 1 week of attaining full enteral feeds - 100ml/kg/day will be retrieved and assessed in study population. Relevant antenatal, postnatal history, demographic details, clinical data and investigations will be collected in a predefined proforma.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • preterm neonates less than or equal to 32 weeks of gestation at birth.
  • Who are offered standard care and who complete their care in the unit till time point of measurement of primary outcome i.e. at least 1 week of full enteral feeds.

排除标准

  • Babies who were transferred out before completion of care, whose primary outcome is not retrievable after transfer.
  • If parents/guardians doesn’t give consent for the study.

结局指标

主要结局

Proportion of very preterm with low zinc levels

时间窗: 1 week after full enteral feeds

次要结局

  • Association between abnormal serum zinc and serum ferritin levels.(1 week after full enteral feeds)
  • Association between abnormal serum zinc levels and gestational age, birth weight, IUGR, sepsis, NEC, ROP requiring laser, BPD and mortality.(During NICU stay)
  • Association between abnormal serum zinc levels in babies who received parentral nutrition vs only enteral nutrition(1 week after full enteral feeds)

研究者

发起方
KIMSHealth
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Abhishek N

KIMSHealth, Thiruvananthapuram.

研究点 (1)

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