Speech of Kids After Neonatal Encephalopathy

NCT07136636 | Recruiting

• 1 other identifier: NNGYK/24844-9/2025
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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 prognostic accuracy of different biomarkers, with a special focus on the ADC values of the corpus callosum. The main questions it aims to answer are:

1. 1.To what extent does hypoxic-ischemic encephalopathy (HIE) in infancy affect intellectual development (IQ), receptive and expressive language abilities at different levels of the language system, and memory capacities related to language development?
2. 2.What is the relationship between early biomarkers of brain injury-such as blood gas levels, lactate, aEEG, and MRI findings (Weeke scoring system, ADC values of the corpus callosum)-and long-term cognitive developmental outcomes?
3. 3.What is the incidence of autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in this high-risk population of infants with HIE?
4. 4.Is there an association between the Weeke Total Score and long-term language developmental outcomes?
5. 5.Can restricted diffusion (ADC values) of the splenium of the corpus callosum serve as an early neuroradiological marker of developmental language disorder (DLD)?

Conditions

HIE - Hypoxic - Ischemic Encephalopathy; Language Delay; Autism; ADHD - Attention Deficit Disorder With Hyperactivity; Specific Language Impairment; Intellectual Developmental Disorder

Keywords

HIE - Hypoxic - Ischemic Encephalopathy; delayed language development; neurodevelopment; MRI; biomarker; corpus callosum diffusion restriction; IQ; newborn prediction tool

Outcome Measures

Primary Outcomes (2)

• Cognitive abilities - WPPSI-IV

  At the age of 4-7 years

• Language abilities - KOBAK

  At the age of 4-7 years

Secondary Outcomes (6)

• Socioeconomic status - Socioeconomic questionnaire

  At the age of 4-7 years

• Parental concerns - Jaworsky Questionnaire

  At the age of 4-7 years

• Social and Communication skills - Social Communication Questionnaire

  At the age of 4-7 years

• Digital screen use - ScreenQ

  At the age of 4-7 years

• ADHD traits - ADHD Rating Scale

  At the age of 4-7 years

Study Arms (1)

Children born with Hypoxic-Ischemic Encephalopathy (HIE)

Eligibility Criteria

• Age: 0 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with HIE

You may qualify if:

• Born at ≥ 35th week of gestation
• Attended follow-up examinations at two years of age
• Has parental informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead
• UiT The Arctic University of Norway: collaborator
• Budapest University of Technology and Economics: collaborator
• Eotvos Lorand University: collaborator

Study Sites (1)

Semmelweis University

Budapest, Hungary

RECRUITING

Related Publications (5)

• Bartha-Doering L, Kollndorfer K, Schwartz E, Fischmeister FPS, Alexopoulos J, Langs G, Prayer D, Kasprian G, Seidl R. The role of the corpus callosum in language network connectivity in children. Dev Sci. 2021 Mar;24(2):e13031. doi: 10.1111/desc.13031. Epub 2020 Sep 1.

  PMID: 32790079 BACKGROUND

• Weeke LC, Groenendaal F, Mudigonda K, Blennow M, Lequin MH, Meiners LC, van Haastert IC, Benders MJ, Hallberg B, de Vries LS. A Novel Magnetic Resonance Imaging Score Predicts Neurodevelopmental Outcome After Perinatal Asphyxia and Therapeutic Hypothermia. J Pediatr. 2018 Jan;192:33-40.e2. doi: 10.1016/j.jpeds.2017.09.043.

  PMID: 29246356 BACKGROUND

• Ni Bhroin M, Kelly L, Sweetman D, Aslam S, O'Dea MI, Hurley T, Slevin M, Murphy J, Byrne AT, Colleran G, Molloy EJ, Bokde ALW. Relationship Between MRI Scoring Systems and Neurodevelopmental Outcome at Two Years in Infants With Neonatal Encephalopathy. Pediatr Neurol. 2022 Jan;126:35-42. doi: 10.1016/j.pediatrneurol.2021.10.005. Epub 2021 Oct 13.

  PMID: 34736061 BACKGROUND

• Chin EM, Jayakumar S, Ramos E, Gerner G, Soares BP, Cristofalo E, Leppert M, Allen M, Parkinson C, Johnston M, Northington F, Burton VJ. Preschool Language Outcomes following Perinatal Hypoxic-Ischemic Encephalopathy in the Age of Therapeutic Hypothermia. Dev Neurosci. 2019 Jun 5:1-11. doi: 10.1159/000499562. Online ahead of print.

  PMID: 31167188 BACKGROUND

• Ouwehand S, Smidt LCA, Dudink J, Benders MJNL, de Vries LS, Groenendaal F, van der Aa NE. Predictors of Outcomes in Hypoxic-Ischemic Encephalopathy following Hypothermia: A Meta-Analysis. Neonatology. 2020;117(4):411-427. doi: 10.1159/000505519. Epub 2020 Apr 1.

  PMID: 32235122 BACKGROUND

MeSH Terms

Conditions

Language Development Disorders; Autistic Disorder; Attention Deficit Disorder with Hyperactivity; Specific Language Disorder; Intellectual Disability

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Learning Disabilities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

HU (1)