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临床试验/NCT03493113
NCT03493113已完成不适用

Transient Hypothyroxinemia of Prematurity: Electrophysiological Changes in the Preterm Infants' Brain, a Retrospective Study

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2011年10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
87
试验地点
1
主要终点
Differences in EEG measures in preterm infants with thyroid dysfunction

研究概览

简要总结

The aim of this study is to investigate differences in electroencephalography (EEG) evolution between preterm infants with and without transient hypothyroxinemia of prematurity (THOP) in order to find differences in the interburst interval and the background pattern and in the maturation of the sleep-wake cycle.

详细描述

  1. Definition of THOP The determination of thyroid hormones (TH) are assay-specific and related to the infants' gestational age (GA) and moment of determination. Immediately after birth, there will be a surge of TH, subsequently followed by a decrease to basal levels. Therefore, it is difficult to obtain reference values.

The investigators plan to set out specific reference values for the preterm patient population, based on the TH laboratory results of cord blood, performed in the clinical laboratory of UZ Leuven and available over the last 4 years. The results will be linked to the gestational age. Dependent whether the data distribution is normal or not, the investigators are planning to use standard deviations or percentiles to classify patients. 2. EEG findings In this retrospective study, quantitative EEG- sleep behavior at (near) term age (GA 36-44 weeks) in preterm infants born <28 weeks GA, will be analyzed (n = 87).

EEGs were taken in the framework of the Resilience study and hereby, parental informed consent was already obtained.

TH function is assessed in preterm infants ≤ 34 weeks as part of the clinical care protocol. No additional blood samples were taken.

Quantitative EEG measures will be compared between the preterm infants with THOP (circulating thyroxine levels< P10) and without THOP. Logisitic regression will be performed to determine the effect of thyroid function as well as other clinical and demographic variables, on functional brain development at term equivalent age. These results will also be linked to long-term neurodevelopment outcome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
24 Weeks 至 27 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • gestational age < 28 weeks
  • serial EEG recordings available
  • thyroid function test on the first day of life and at the end of the first week of life available

排除标准

  • Presence of congenital abnormalities

结局指标

主要结局

Differences in EEG measures in preterm infants with thyroid dysfunction

时间窗: November 2011 - November 2017

Quantitative EEG measures will be compared between the preterm infants with THOP (circulating T4 level\< P10) and without THOP. In a subgroup of these preterm patients (n=42) sequential EEGs, recorded during their stay at the NICU, are available. These EEGs will be analyzed in a fully automatic way to assess functional EEG- brain maturation.

次要结局

  • Neurodevelopmental disturbances due to THOP and predicted by EEG alterations(November 2011 - November 2019)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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