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Speech of Kids After Neonatal Encephalopathy

NCT07136636 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 93

Last updated 2025-08-22

No results posted yet for this study

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.

Conditions

  • HIE - Hypoxic - Ischemic Encephalopathy
  • Language Delay
  • Autism
  • ADHD - Attention Deficit Disorder With Hyperactivity
  • Specific Language Impairment
  • Intellectual Developmental Disorder

Sponsors & Collaborators

  • UiT The Arctic University of Norway

    collaborator OTHER

  • Budapest University of Technology and Economics

    collaborator OTHER

  • Eotvos Lorand University

    collaborator OTHER

  • Semmelweis University

    lead OTHER

Eligibility

Min Age
0 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Hungary

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07136636 on ClinicalTrials.gov