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临床试验/NCT06018012
NCT06018012已完成不适用

Magnetic Resonance Spectroscopy and Auditory Brain- Stem Response Audiometry as Early Predictors of Bilirubin-Induced Neurologic Dysfunction in Full-term Jaundiced Neonates

Tanta University1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
Bilirubin level and MRS abnormality

研究概览

简要总结

The aim of the research was to define the role of MRS and ABR as early predictors of bilirubin-induced neurologic dysfunction (BIND) in full-term neonates who required intervention (phototherapy or exchange transfusion).

详细描述

Neonatal jaundice is a prevalent condition. It's typically a harmless phase that occurs as the body adjusts to bilirubin levels after birth, representing a balance between its production and elimination. When there's an increase in bilirubin production and a decrease in elimination, infants become at risk for dangerous hyperbilirubinemia, potentially leading to bilirubin encephalopathy.

The range of neurological issues caused by excessive bilirubin is referred to as bilirubin-induced neurologic dysfunction. Detecting this condition early is crucial to prevent irreversible brain damage. Some of the neurological effects include gliosis, demyelination, and interference with glutamate uptake by astrocytes in the basal ganglia. Magnetic resonance spectroscopy (MRS) is an advanced imaging technique that holds promise for identifying these metabolic changes and aiding in the diagnosis and evaluation of neonates with hyperbilirubinemia.

Bilirubin neurotoxicity particularly affects the auditory system, starting with the brainstem cochlear nuclei, followed by the auditory nerve. This damage can occur even without the classic signs of bilirubin encephalopathy and is known as auditory neuropathy spectrum disorder (ANSD). ANSD is characterized by abnormal auditory neural function, while cochlear microphonics and otoacoustic emissions remain normal.

The impact on hearing can vary from subtle issues in sound processing to complete deafness. Abnormal results in auditory brainstem response (ABR) tests can indicate the presence of acute bilirubin encephalopathy (ABE), serving as the most common and earliest sign of ABE.

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
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • This study included term, appropriate for gestational age (AGA) neonates with pathological unconjugated hyperbilirubinemia who were candidates for intervention (Intensive phototherapy versus Exchange transfusion) using the American Academy of Pediatrics guidelines; 2004.

排除标准

  • Preterm neonates (less than 37 weeks).
  • Clinically moderate and severe acute bilirubin encephalopathy according to modified Bilirubin-induced neurologic dysfunction (BIND-M) score.
  • Neonates born with birth asphyxia and/or poor Apgar score.
  • Neonates with sepsis including CNS infection.
  • Neonates with family history of childhood hearing loss.
  • Congenital infection.
  • Chromosomal abnormalities.
  • Congenital ear anomalies associated with hearing loss or brain abnormalities including craniofacial anomalies.
  • Patients who were receiving ototoxic drugs as aminoglycosides.
  • Conjugated hyperbilirubinemia.

结局指标

主要结局

Bilirubin level and MRS abnormality

时间窗: 2 years

Finding out the lowest level of total serum bilirubin at which MRS abnormalities were found, in comparison to age.

Early detection of neurological abnormalities using MRS metabolic ratios in high-risk neonates without oblivious clinical signs

时间窗: 2 years

Early detection of neurological abnormalities in high-risk neonates, without oblivious clinical signs, chemically by using MRS metabolic ratio ( low NAA/Cr, NAA/Cho ratios, and high Lac/Cr ratio).

Early detection of neurological abnormalities using ABR parameters in high-risk neonates without oblivious clinical signs

时间窗: 2 years

Early detection of neurological abnormalities in high-risk neonates, without oblivious clinical signs, functionally through ABR parameters ( prolonged wave III peak latency, wave V peak latency, I-III interpeak interval, and I-V interpeak interval )

Bilirubin level and auditory abnormality

时间窗: 2 years

Finding out the lowest level of total serum bilirubin at which auditory pathway abnormality was found, in comparison to age.

次要结局

  • Discriminative capacity of MRS for acute bilirubin encephalopathy(2 years)
  • Discriminative capacity of ABR for acute bilirubin encephalopathy(2 years)

研究者

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

Lamiaa Khaled Zidan

Assistant lecturer

Tanta University

研究点 (1)

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