The role of the corpus callosum in language network connectivity in children.
Lisa Bartha-Doering, Kathrin Kollndorfer, Ernst Schwartz...
https://pubmed.ncbi.nlm.nih.gov/32790079Actively Recruiting
Led by Semmelweis University · Updated on 2025-08-22
93
Participants Needed
1
Research Sites
N/A
Total Duration
S
Semmelweis University
Lead Sponsor
U
UiT The Arctic University of Norway
Collaborating Sponsor
Researchers are studying children aged 4 to 7 years who were born with moderate to severe hypoxic-ischemic encephalopathy (HIE) and treated with therapeutic hypothermia. The study aims to identify early signs of delayed language development by examining biomarkers such as blood gas levels, brain activity, and MRI findings, with a focus on the corpus callosum's ADC values. It also investigates the impact of HIE on intellectual and language development, memory, and the incidence of autism spectrum disorder and ADHD in this population. The study involves a detailed review of clinical, laboratory, and imaging data collected during the neonatal period, including blood gas values, cerebral activity recordings during the first hours of life, and MRI scans performed around day 4 to 5 after birth. These MRI scans are reanalyzed using the Weeke MRI scoring system. Neurodevelopmental assessments were done at age 2 using the Bayley Scales, and a second comprehensive assessment is planned at ages 4 to 7 years to evaluate intelligence and language abilities using standardized tools like the WPPSI-IV and KOBAK tests. Participants will undergo neurodevelopmental evaluations including IQ testing, detailed language assessments, and questionnaires completed by parents covering socioeconomic status, social communication, screen time, ADHD traits, and behavior. The study measures cognitive and language abilities as primary outcomes and collects data on social and behavioral aspects as secondary outcomes. Recruitment and data collection are scheduled from April 2025 to December 2026, involving children who had prior follow-up and whose parents consent to continued assessment.
CONDITIONS
Speech of Kids After Neonatal Encephalopathy
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Neonatal period up to 1 week after birth
Participants' neonatal clinical, laboratory, and imaging data collected during the neonatal period are reviewed, including blood gas values, cerebral activity monitoring, and MRI scans performed within the first week of life.
Data collected from routine neonatal care; no additional visits required
Duration - At 2 years of age
Participants undergo neurodevelopmental assessments at 2 years of age using standardized tools to evaluate mental and psychomotor development.
1 visit (in-person)
Duration - At ages 4 to 7 years
Participants aged 4 to 7 years complete a second neurodevelopmental assessment including intelligence and language skills tests, along with parental questionnaires regarding socioeconomic status, behavior, and other factors.
1 visit (in-person)
Total: 1 location
1
Semmelweis University
Budapest, Hungary
Actively Recruiting
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Lisa Bartha-Doering, Kathrin Kollndorfer, Ernst Schwartz...
https://pubmed.ncbi.nlm.nih.gov/32790079Lauren C Weeke, Floris Groenendaal, Kalyani Mudigonda...
https://pubmed.ncbi.nlm.nih.gov/29246356Megan Ní Bhroin, Lynne Kelly, Deirdre Sweetman...
https://pubmed.ncbi.nlm.nih.gov/34736061Eric M Chin, Srishti Jayakumar, Ezequiel Ramos...
https://pubmed.ncbi.nlm.nih.gov/31167188Sabine Ouwehand, Lisanne C A Smidt, Jeroen Dudink...
https://pubmed.ncbi.nlm.nih.gov/32235122