Actively Recruiting

Age: 0Years - 7Years
All Genders
NCT07136636

Speech of Kids After Neonatal Encephalopathy

Led by Semmelweis University · Updated on 2025-08-22

93

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

Sponsors

S

Semmelweis University

Lead Sponsor

U

UiT The Arctic University of Norway

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Speech of Kids After Neonatal Encephalopathy

Who Can Participate

Age: 0Years - 7Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children born between 2017 and 2023 with moderate to severe HIE
  • Born at 63 35th week of gestation
  • Attended follow-up examinations at two years of age
  • Has parental informed consent
Not Eligible

You will not qualify if you...

  • Hearing loss
  • Multilingual language environment
  • Congenital abnormalities
  • Metabolic disease
  • Sudden unexpected postnatal collapse
  • Brain injury not caused by HIE
  • Severe motor impairment defined as a score <70 on the psychomotor development index (PDI) at 2 years of age

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Semmelweis University

Budapest, Hungary

Actively Recruiting

Loading map...

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here