NCT07136636 Speech of Kids After Neonatal Encephalopathy
| NCT ID | NCT07136636 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Semmelweis University |
| Condition | HIE - Hypoxic - Ischemic Encephalopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 93 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 93 participants in total. It began in 2025-04-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Children born between 2017 and 2023 with moderate to severe HIE, treated with therapeutic hypothermia at Semmelweis University Children's Hospital. Inclusion criteria 1. Born at ≥ 35th week of gestation 2. Attended follow-up examinations at two years of age 3. Has parental informed consent Exclusion criteria 1. Hearing loss 2. Multilingual language environment 3. Congenital abnormalities 4. Metabolic disease 5. Sudden unexpected postnatal collapse 6. Brain injury not caused by HIE 7. Severe motor impairment defined as a score \<70 on the psychomotor development index (PDI) at 2 years of age
Frequently Asked Questions
Who can join the NCT07136636 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 7 Years, studying HIE - Hypoxic - Ischemic Encephalopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07136636 currently recruiting?
Yes, NCT07136636 is actively recruiting participants. Visit ClinicalTrials.gov or contact Semmelweis University to inquire about joining.
Where is the NCT07136636 trial being conducted?
This trial is being conducted at Budapest, Hungary.
Who is sponsoring the NCT07136636 clinical trial?
NCT07136636 is sponsored by Semmelweis University. The trial plans to enroll 93 participants.