Speech and language outcomes after neonatal hypoxic-ischemic encephalopathy
Investigating the Prognostic Accuracy of Different Biomarkers for Detection of Developmental Language Disorder in Children With Neonatal Encephalopathy
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 type | Observational |
|---|---|
| Enrollment | 93 (estimated) |
| Ages | 0 Years to 7 Years |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Locations | 1 site (Budapest) |
| Trial ID | NCT07136636 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Budapest
- Semmelweis University — Budapest, Hungary (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.