Early Brain Markers and Later Language Development After Neonatal Encephalopathy
Follows children with birth brain injury to find early signs of language delay.
Plain-language title generated from the registry record
Registry title: Speech of Kids After Neonatal Encephalopathy
Key facts
- Where
- Budapest, HungarySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 0 and 7 years old?
Source: NCT07136636, who can take part
Where in Hungary
- Semmelweis UniversityBudapest, HungaryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Semmelweis University
- Trial code
- NCT07136636
- Record updated
- 22 August 2025
- Original description
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).Read full original descriptionShow less
Investigating the Prognostic Accuracy of Different Biomarkers for Detection of Developmental Language Disorder in Children With Neonatal Encephalopathy
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:
1. 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? 2. 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? 3. What is the incidence of autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in this high-risk population of infants with HIE? 4. Is there an association between the Weeke Total Score and long-term language developmental outcomes? 5. 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.
Inclusion: Born at ≥ 35th week of gestation; Attended follow-up examinations at two years of age; Has parental informed consent.
Exclusion: Metabolic disease; Severe motor impairment defined as a score <70 on the psychomotor development index (PDI) at 2 years of age; Hearing loss; Multilingual language environment; Congenital abnormalities; Sudden unexpected postnatal collapse; Brain injury not caused by HIE.
Children born between 2017 and 2023 with moderate to severe HIE, treated with therapeutic hypothermia at Semmelweis University Children's Hospital.