About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Born at ≥ 35th week of gestation
Attended follow-up examinations at two years of age
Has parental informed consent
Disqualifiers
Hearing loss
Multilingual language environment
Congenital abnormalities
Metabolic disease
Trial population
Children with HIE
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Cognitive abilities - WPPSI-IV
Language abilities - KOBAK
Secondary outcomes
Socioeconomic status - Socioeconomic questionnaire
Parental concerns - Jaworsky Questionnaire
Social and Communication skills - Social Communication Questionnaire
Digital screen use - ScreenQ
Sponsors and contacts
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Semmelweis University
Lead sponsor
UiT The Arctic University of Norway
Collaborator
Budapest University of Technology and Economics
Collaborator
Eotvos Lorand University
Collaborator