Home › Trials › NCT07136636
Clinical trial Recruiting at 1 site Observational Ages 0 to 7

Speech and language outcomes after neonatal hypoxic-ischemic encephalopathy

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

Run by Semmelweis University · NCT07136636 · Data updated 2026-11-12

We will see if early newborn tests—blood gas and lactate values, aEEG, and MRI (especially corpus callosum ADC)—can predict language, IQ, memory, or later diagnoses like autism and ADHD in children aged 4–7 who had moderate to severe HIE and therapeutic hypothermia.

Quick facts

Study typeObservational
Ages0 Years to 7 Years
SexAll
Enrollment93 (estimated)
SponsorSemmelweis University
Academic / other
Locations1 site (Budapest)
StatusRecruiting
StartedApril 1, 2025
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedAugust 22, 2025
Trial IDNCT07136636 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children born ≥35 weeks between 2017–2023 who had moderate to severe HIE treated with therapeutic hypothermia at Semmelweis University, attended the two‑year follow-up, and whose parents provide consent are the intended participants.

Probably not a fit

Children with non‑HIE brain injury, congenital abnormalities, metabolic disease, hearing loss, multilingual home environments, severe motor impairment at 2 years, or those not treated/followed at the study center are unlikely to benefit from these prognostic results.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This ambispective, single-center cohort will reanalyze neonatal clinical, laboratory, aEEG, and MRI data for children treated with therapeutic hypothermia for moderate to severe HIE and who had standardized neurodevelopmental follow-up at 2 years. Neonatal MRI scans will be rescored using the Weeke system and corpus callosum ADC values will be extracted for prognostic testing. Developmental outcomes at ages 4–7 will be compared to early biomarkers to determine which markers best predict later language, cognitive, and memory performance and the incidence of ASD/ADHD. Recruitment and data collection are planned at Semmelweis University between April 1, 2025 and December 31, 2026.

Why it matters

Potential benefit: If successful, the findings could allow earlier and more accurate identification of infants at high risk for language or cognitive problems after HIE, guiding targeted early interventions and follow-up.

How similar studies have gone: Prior research has linked neonatal MRI patterns, aEEG, and some blood markers to later neurodevelopmental outcomes, but focusing on corpus callosum ADC within an ambispective cohort to predict language and ASD/ADHD risk is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Semmelweis University
    Budapest, Hungary     Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
HIE - Hypoxic - Ischemic Encephalopathy 3Language Delay 6Autism 558ADHD - Attention Deficit Disorder With Hyperactivity 18Specific Language Impairment 2Intellectual Developmental Disorder 4Semmelweis University 35
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.