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临床试验/CTRI/2022/11/047101
CTRI/2022/11/047101尚未招募不适用

To determine the incidence of latent iron deficiency in neonates more than 34 weeks with and without risk factors for poor in utero iron status

Command Hospital Airforce Bangalore1 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2022年11月14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
650
试验地点
1
主要终点
To compare the incidence of latent iron deficiency in neonates more than 34 weeks with and without risk factors for poor in utero iron status at birth

研究概览

简要总结

Iron is an essential micronutrient that plays a significant role in critical cellular functions in all organ systems in all species. Iron plays a fundamental role in neural development. It takes part in the myelination and synaptogenesis processes. The fetus obtains iron from the mother through the placenta and full-term infants are usually born with ample amounts of body iron. However, there are certain conditions which can negatively affect the fetal iron status. These include maternal iron deficiency, prematurity, maternal diabetes mellitus, pre-eclampsia, maternal smoking, and intrauterine growth restriction during pregnancy. These conditions have been associated with decreased iron transfer to the fetus and often lead to in utero iron deficiency. The negative iron balance results in hierarchical loss of tissue iron where iron depletion occurs in the brain before it occurs in the red blood cells. The negative iron status that occurs when brain iron may be depleted but red blood cells are not affected is termed as latent iron deficiency. Latent Iron Deficiency can be defined as serum ferritin level between 11 to 75 ng/ml with normal hemoglobin.Such infants could exhaust their iron stores much earlier and become iron deficient before 6 months of age . Identification of such infants becomes important as in utero LID can result in delayed neuronal maturation and abnormal neurological outcomes during childhood.

As very little is known about the incidence of in utero LID and the risk factors associated with it,we are aiming to determine the incidence of LID in pregnancy with and without risk factors for poor in utero iron status through our study.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 1.00 Day(s)(—)
性别
All

入选标准

  • All new born babies (NBB) born at CHAF Bangalore with gestational age ≥ 34 weeks.

排除标准

  • 1.New born babies with gestational age < 34 weeks.
  • 2.Any maternal h/o hemoglobinopathies or h/o blood transfusion during the current pregnancy.
  • 3.Any maternal h/o third trimester infection/ chorioamnionitis.
  • 4.NBB with chromosomal diseases or severe craniofacial anomalies 5.NBB with bleeding disorders/ congenital anemias/ hemolytic diseases.
  • 6.NBB with obvious iron deficiency (serum ferritin <11 ng/mL).
  • 7.Refusal of consent.

结局指标

主要结局

To compare the incidence of latent iron deficiency in neonates more than 34 weeks with and without risk factors for poor in utero iron status at birth

时间窗: From birth to within 72 hours of life

次要结局

  • To study the correlation between maternal iron status and neonatal iron status(at birth)
  • To compare the iron status of the infant(at birth and 4-6 months of age)

研究者

发起方
Command Hospital Airforce Bangalore
申办方类型
Government medical college

研究点 (1)

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