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NCT07136636Recruiting

Speech of Kids After Neonatal Encephalopathy

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

Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
93 (estimated)
First submitted
14 Aug 2025
Start date
1 Apr 2025
Primary completion date
Dec 2026
Lead sponsor
Semmelweis University
Diseases
Autism
NCT number
NCT07136636

What you commit to

  • Study type: Observational
  • Planned participants: 93
  • From 1 Apr 2025 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Metabolic disease

Age

  • Severe motor impairment defined as a score \<70 on the psychomotor development index (PDI) at 2 years of age

Other

  • Hearing loss
  • Multilingual language environment
  • Congenital abnormalities
  • Sudden unexpected postnatal collapse
  • Brain injury not caused by HIE

Who the study is looking for

  • Born at ≥ 35th week of gestation
  • Attended follow-up examinations at two years of age
  • Has parental informed consent

Criteria the registry did not label

  • Children born between 2017 and 2023 with moderate to severe HIE, treated with therapeutic hypothermia at Semmelweis University Children's Hospital.

Age in the registry: 0 years to 7 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
Semmelweis University
Coordinator of this site? Confirm its status
BudapestHungaryRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.