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临床试验/NCT02503397
NCT02503397已完成不适用

Latent Iron Deficiency at Birth Influences Auditory Neural Maturation in Late Preterm and Term Infants

Sir Ganga Ram Hospital0 个研究点目标入组 90 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
主要终点
Auditory neural maturation

研究概览

简要总结

This study evaluates auditory neural maturation by auditory brainstem evoked response in late preterm and term infants with in utero iron deficiency compared with neonates with normal in utero iron status.

详细描述

Iron is an essential nutrient for brain development. During early human development, iron is required for multiple neurodevelopmental processes. To meet the iron requirements of a developing brain, active transfer of iron occurs across the placenta during the last trimester of pregnancy and therefore most term infants have iron replete status at birth. However, maternal iron deficiency during pregnancy, a global health problem, can negatively affect the fetal iron status. In addition, prematurity, maternal diabetes mellitus, preeclampsia, maternal smoking, and intrauterine growth restriction during pregnancy have also been associated with decreased iron transfer to the fetus often leading to in utero iron deficiency.

Cord serum ferritin (SF) level at birth provides a good measurement of fetal tissue iron storage concentration and is therefore often used to evaluate in utero iron status. The absolute and interpeak latencies on auditory brainstem evoked response (ABR) are often used as surrogate outcome measures for neural maturation in the neonates. The absolute latencies for each of these ABR waves and the interpeak latencies (IPL, I-III, III-V, and I-V) are influenced by the degree of myelination, neuronal development, synaptic function, and axonal growth in the auditory nervous system. The absolute latencies and IPL decrease as the auditory neural system matures with age in neonates.

Although iron is essential for auditory neural maturation during the perinatal period, there is a paucity of data regarding the concomitant effect of in utero iron deficiency on auditory neural maturation in late preterm and term infants. The present prospective study is planned with an objective to determine the association of in utero iron deficiency as evaluated by cord ferritin with auditory neural maturation at birth in ≥ 34 weeks GA infants.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Neonates born between 34 - 42 weeks of gestation at Sir Ganga Ram Hospital, New Delhi

排除标准

  • Infants with
  • craniofacial anomalies
  • chromosomal disorders,
  • hemolytic disease (coomb's positive),
  • multiple gestation,
  • history of third trimester maternal infections,
  • clinical chorioamnionitis,
  • Apgar score < 5 at 5 minutes,
  • TORCH infections (toxoplasmosis, other infections, rubella, cytomegalovirus infection and herpes simplex),
  • clinical or culture proven sepsis,
  • admission to the Neonatal Intensive Care Unit,
  • infants on whom cord blood not collected and on whom ABR could not be performed

结局指标

主要结局

Auditory neural maturation

时间窗: 3 days

Auditory neural maturation as assessed by auditory brainstem response at birth in≥ 34 weeks gestational age infants with normal in utero iron status compared with infants with in utero latent iron deficiency

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vivek Choudhury

DNB trainee in Neonatology

Sir Ganga Ram Hospital

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