Status:
RECRUITING
Speech of Kids After Neonatal Encephalopathy
Lead Sponsor:
Semmelweis University
Collaborating Sponsors:
UiT The Arctic University of Norway
Budapest University of Technology and Economics
Conditions:
HIE - Hypoxic - Ischemic Encephalopathy
Language Delay
Eligibility:
All Genders
Up to 7 years
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 prognosti...
Detailed Description
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) a...
Eligibility Criteria
Inclusion
- Children born between 2017 and 2023 with moderate to severe HIE, treated with therapeutic hypothermia at Semmelweis University Children's Hospital.
- Inclusion criteria
- Born at ≥ 35th week of gestation
- Attended follow-up examinations at two years of age
- Has parental informed consent
- Exclusion criteria
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT07136636
Start Date
April 1 2025
End Date
December 1 2026
Last Update
August 22 2025
Active Locations (1)
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1
Semmelweis University
Budapest, Hungary