An observational study in HIE - Hypoxic - Ischemic Encephalopathy, Language Delay and Autism, sponsored by Semmelweis University. Recruiting at 1 site in Hungary. Open to participants aged 0 Years to 7 Years. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Semmelweis University · Observational
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:
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.
This ambispective, single-center cohort study will investigate the cognitive and language development of children aged 4-7 years who were previously treated for hypoxic-ischemic encephalopathy (HIE) and underwent standardized neurodevelopmental assessment at two years of age. In addition to developmental outcomes, the study will incorporate clinical, laboratory, and imaging data collected during the neonatal period. All available neonatal MRI scans will be re-evaluated according to predefined criteria. Recruitment and data collection will take place from April 1, 2025, to December 31, 2026. The study population will include children whose parents provided consent for follow-up assessments at the two-year evaluation.
Phase 1.: Blood gas values like pH, base deficit, PCO2, PO2, HCO3, and lactate were registered. aEEG cerebral activity was recorded using continuous single channel (biparietal, P3-P4) aEEG monitoring. It started before 6 hours of age.
Phase 2. : MRI scans was perfomed between the 4-5th day of postnatal age. The MRI scans will be reanalyzed, using the Weeke MRI scoring system.
Phase 3. : At the age of 2 years participating children underwent neurodevelopemntal follow-up, where the Bayley Scales of Infant and Toddler Development, Second Edition (Bayley-II) was used. It is a standardized tool for assessing the developmental functioning of children from 1 to 42 months of age. The test provides both a Mental Development Index (MDI) and a Psychomotor Development Index (PDI) to summarize performance in key areas.
Phase 4.: At the age of 4-7 years the children will undergo their second neurodevelopmental assessment. Within this assessment we will administer the following:
Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV), which assesses Full-Scale IQ, Verbal IQ, and Performance IQ in children aged 4 years to 7 years.
Complex Test of Spoken Language Skills (KOBAK), the first comprehensive, standardized language assessment developed for Hungarian-speaking children. The KOBAK comprises 16 subtests evaluating expressive and receptive language functions across multiple domains (phonology, lexical semantics, morphology, syntax, and pragmatics), as well as speech motor functions and verbal working memory. The test enables evidence-based differentiation of average, above-average, and below-average language abilities; provides a detailed language profile; supports the assessment of school readiness; and facilitates screening, diagnosis, differential diagnosis, and longitudinal monitoring of language development.
As part of the neurodevelopmental assessment, parents will complete several questionnaires:
Socioeconomic Questionnaire (assessing parental education, income, and related variables) Jaworsky Questionnaire Social Communication Questionnaire (SCQ) ScreenQ ADHD Rating Scale Strengths and Difficulties Questionnaire (SDQ)
121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.
This study's planned enrollment of 93 is below the median of 131 across 15 observational studies indexed under Language Development Disorders.
Browse Language Development Disorders studies →Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.
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Children with HIE
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children born between 2017 and 2023 with moderate to severe HIE, treated with therapeutic hypothermia at Semmelweis University Children's Hospital.
Inclusion criteria
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cognitive abilities - WPPSI-IV
Time frame: At the age of 4-7 years
Language abilities - KOBAK
Time frame: At the age of 4-7 years
Socioeconomic status - Socioeconomic questionnaire
Time frame: At the age of 4-7 years
Parental concerns - Jaworsky Questionnaire
Time frame: At the age of 4-7 years
Social and Communication skills - Social Communication Questionnaire
Time frame: At the age of 4-7 years
Digital screen use - ScreenQ
Time frame: At the age of 4-7 years
ADHD traits - ADHD Rating Scale
Time frame: At the age of 4-7 years
Behavior - Strengths and Difficulties Questionnaire
Time frame: At the age of 4-7 years
Started Apr 2025 (actual). Primary completion is estimated for Dec 2026, 20 months after the start.
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