Actively Recruiting

Age: 0Years - 7Years
All Genders
ID07136636

Investigating Biomarkers to Detect Developmental Language Disorder in Children With Neonatal Encephalopathy A Study on Prognostic Accuracy in Hypoxic-Ischemic Encephalopathy

Led by Semmelweis University · Updated on 2025-08-22

93

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Semmelweis University

Lead Sponsor

U

UiT The Arctic University of Norway

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Speech of Kids After Neonatal Encephalopathy

Who Can Participate

Age: 0Years - 7Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Born between 2017 and 2023 with moderate to severe HIE
  • Born at or after the 35th week of gestation
  • Attended follow-up examinations at 2 years of age
  • Has parental informed consent
Not Eligible

You will not qualify if you...

  • Hearing loss
  • Multilingual language environment
  • Congenital abnormalities
  • Metabolic disease
  • Sudden unexpected postnatal collapse
  • Brain injury not caused by HIE
  • Severe motor impairment with a psychomotor development index score below 70 at 2 years of age

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Monitoring

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)

Long-term Monitoring

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)

Trial Site Locations

Total: 1 location

1

Semmelweis University

Budapest, Hungary

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

A Novel Magnetic Resonance Imaging Score Predicts Neurodevelopmental Outcome After Perinatal Asphyxia and Therapeutic Hypothermia.

Lauren C Weeke, Floris Groenendaal, Kalyani Mudigonda...

https://pubmed.ncbi.nlm.nih.gov/29246356

Relationship Between MRI Scoring Systems and Neurodevelopmental Outcome at Two Years in Infants With Neonatal Encephalopathy.

Megan Ní Bhroin, Lynne Kelly, Deirdre Sweetman...

https://pubmed.ncbi.nlm.nih.gov/34736061

Preschool Language Outcomes following Perinatal Hypoxic-Ischemic Encephalopathy in the Age of Therapeutic Hypothermia.

Eric M Chin, Srishti Jayakumar, Ezequiel Ramos...

https://pubmed.ncbi.nlm.nih.gov/31167188