Investigating the Prognostic Accuracy of Different Biomarkers for Detection of Developmental Language Disorder in Children With Neonatal Encephalopathy

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Maximum Age: 7
Healthy Volunteers: f
View:

• Born at ≥ 35th week of gestation

• Attended follow-up examinations at two years of age

• Has parental informed consent

Locations
Other Locations
Hungary
Semmelweis University
RECRUITING
Budapest
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 93
Treatments
Children born with Hypoxic-Ischemic Encephalopathy (HIE)
Sponsors
Leads: Semmelweis University
Collaborators: UiT The Arctic University of Norway, Eotvos Lorand University, Budapest University of Technology and Economics

This content was sourced from clinicaltrials.gov

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