Investigating the Prognostic Accuracy of Different Biomarkers for Detection of Developmental Language Disorder in Children With Neonatal Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Cognitive abilities - WPPSI-IV
研究概览
简要总结
The goal of this ambispective cohort study is to reveal the early indicators of delayed language development in children born with hypoxic-ischemic encephalopathy (HIE).
We will examine the prognostic accuracy of different biomarkers, with a special focus on the ADC values of the corpus callosum.
The main questions it aims to answer are:
- To what extent does hypoxic-ischemic encephalopathy (HIE) in infancy affect intellectual development (IQ), receptive and expressive language abilities at different levels of the language system, and memory capacities related to language development?
- What is the relationship between early biomarkers of brain injury-such as blood gas levels, lactate, aEEG, and MRI findings (Weeke scoring system, ADC values of the corpus callosum)-and long-term cognitive developmental outcomes?
- What is the incidence of autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in this high-risk population of infants with HIE?
- Is there an association between the Weeke Total Score and long-term language developmental outcomes?
- Can restricted diffusion (ADC values) of the splenium of the corpus callosum serve as an early neuroradiological marker of developmental language disorder (DLD)?
Our participants are children born between 2017 and 2023 with moderate to severe HIE, treated with therapeutic hypothermia at Semmelwies University Children's Hospital. During their first days of life, several neonatal measurements were taken (blood gas markers, aEEG etc.), and at day 4-5, they had an MRI scan of their brain. The MRI scans will be reanalyzed, using the Weeke MRI scoring system. These children underwent a neurodevelopmental follow-up at the age of 2 years and currently, they will have another follow-up at the age of 4-7 years.
详细描述
This ambispective, single-center cohort study will investigate the cognitive and language development of children aged 4-7 years who were previously treated for hypoxic-ischemic encephalopathy (HIE) and underwent standardized neurodevelopmental assessment at two years of age. In addition to developmental outcomes, the study will incorporate clinical, laboratory, and imaging data collected during the neonatal period. All available neonatal MRI scans will be re-evaluated according to predefined criteria. Recruitment and data collection will take place from April 1, 2025, to December 31, 2026. The study population will include children whose parents provided consent for follow-up assessments at the two-year evaluation.
Phase 1.: Blood gas values like pH, base deficit, PCO2, PO2, HCO3, and lactate were registered. aEEG cerebral activity was recorded using continuous single channel (biparietal, P3-P4) aEEG monitoring. It started before 6 hours of age.
Phase 2. : MRI scans was perfomed between the 4-5th day of postnatal age. The MRI scans will be reanalyzed, using the Weeke MRI scoring system.
Phase 3. : At the age of 2 years participating children underwent neurodevelopemntal follow-up, where the Bayley Scales of Infant and Toddler Development, Second Edition (Bayley-II) was used. It is a standardized tool for assessing the developmental functioning of children from 1 to 42 months of age. The test provides both a Mental Development Index (MDI) and a Psychomotor Development Index (PDI) to summarize performance in key areas.
Phase 4.: At the age of 4-7 years the children will undergo their second neurodevelopmental assessment. Within this assessment we will administer the following:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 0 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cognitive abilities - WPPSI-IV
时间窗: At the age of 4-7 years
Language abilities - KOBAK
时间窗: At the age of 4-7 years
次要结局
- Parental concerns - Jaworsky Questionnaire(At the age of 4-7 years)
- Behavior - Strengths and Difficulties Questionnaire(At the age of 4-7 years)
- Socioeconomic status - Socioeconomic questionnaire(At the age of 4-7 years)
- Social and Communication skills - Social Communication Questionnaire(At the age of 4-7 years)
- Digital screen use - ScreenQ(At the age of 4-7 years)
- ADHD traits - ADHD Rating Scale(At the age of 4-7 years)