Speech of Kids After Neonatal Encephalopathy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-7
SponsorSemmelweis University

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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

93 Participants
are grouped into 1 trial group

Sponsors and collaborators

Semmelweis University

Lead sponsor

UiT The Arctic University of Norway

Collaborator

Budapest University of Technology and Economics

Collaborator

Eotvos Lorand University

Collaborator