Academic Journal
Study protocol of the Speech of children After Neonatal Encephalopathy (SANE): a single-centre prospective cohort study.
| Τίτλος: | Study protocol of the Speech of children After Neonatal Encephalopathy (SANE): a single-centre prospective cohort study. |
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| Συγγραφείς: | Bodócs DL; Department of Neonatology, Pediatric Centre, Semmelweis University, Budapest, Hungary.; Center for Translational Medicine, Semmelweis University, Budapest, Hungary., Ragó A; Department of Psychology, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway., Farkas N; Center for Translational Medicine, Semmelweis University, Budapest, Hungary.; Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary., Lakatos A; Department of Radiology, Medical Imaging Centre, Semmelweis University, Budapest, Hungary.; Faculty of Health Sciences, University of Miskolc, Miskolc, Hungary., Kas B; Institute for General and Hungarian Linguistics, Hungarian Research Centre for Linguistics, Budapest, Hungary.; MTA-ELTE Language-Learning Disorders Research Group, Eötvös Loránd University, Budapest, Hungary., Lukács Á; Institute for General and Hungarian Linguistics, Hungarian Research Centre for Linguistics, Budapest, Hungary.; MTA-ELTE Language-Learning Disorders Research Group, Eötvös Loránd University, Budapest, Hungary., Jermendy Á; Department of Neonatology, Pediatric Centre, Semmelweis University, Budapest, Hungary., Hernádfői M; Center for Translational Medicine, Semmelweis University, Budapest, Hungary.; Bethesda Children's Hospital, Budapest, Hungary., Lökkös E; Department of Neonatology, Pediatric Centre, Semmelweis University, Budapest, Hungary., Kiss N; Center for Translational Medicine, Semmelweis University, Budapest, Hungary.; Department of Dermatology, Venereology and Dermatooncology, Semmelweis University, Budapest, Hungary., Bánvölgyi A; Center for Translational Medicine, Semmelweis University, Budapest, Hungary.; Department of Dermatology, Venereology and Dermatooncology, Semmelweis University, Budapest, Hungary., Major J; Center for Translational Medicine, Semmelweis University, Budapest, Hungary.; Bethesda Children's Hospital, Budapest, Hungary.; Institute of Behavioural Sciences, Semmelweis University, Budapest, Hungary., Hegyi P; Center for Translational Medicine, Semmelweis University, Budapest, Hungary.; Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.; Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary., Szabó M; Department of Neonatology, Pediatric Centre, Semmelweis University, Budapest, Hungary.; Center for Translational Medicine, Semmelweis University, Budapest, Hungary., Varga Z; Department of Neonatology, Pediatric Centre, Semmelweis University, Budapest, Hungary varga.zsuzsanna2@semmelweis.hu.; Center for Translational Medicine, Semmelweis University, Budapest, Hungary. |
| Πηγή: | BMJ open [BMJ Open] 2026 Aug 10; Vol. 16 (8), pp. e120474. Date of Electronic Publication: 2026 Aug 10. |
| Τύπος έκδοσης: | Clinical Trial Protocol; Journal Article |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| Ιατρικοί όροι (MeSH): | Asphyxia Neonatorum*/therapy , Asphyxia Neonatorum*/complications , Brain Diseases*/therapy , Brain Diseases*/complications , Hypothermia, Induced*/adverse effects , Language Development Disorders*/etiology , Language Development*, Child ; Child, Preschool ; Female ; Humans ; Infant, Newborn ; Male ; Prospective Studies ; Research Design ; Observational Studies as Topic |
| Περίληψη: | Introduction: Language development is a key determinant of academic achievement and psychosocial outcome. Due to the therapeutic hypothermia procedure, 75% of children diagnosed with moderate to severe neonatal encephalopathy (E) survive without serious neurological sequelae. Several studies have already revealed the overall cognitive deficits of these infants; however, their long-term language developmental specificities and their attendant neonatal risk markers remain under-investigated. Methods and Analyses: In our single-centre prospective cohort study (n≈128), we will include only those children with perinatal asphyxia who meet the stepwise criteria of the Total Body Hypothermia (TOBY) study and who survive NE without functional motor deficits and moderate/severe overall cognitive deficits at the second-year follow-up examination. The NE survivors included and cared for in the Level III Neonatal Intensive Care Unit of the Pediatric Center, Semmelweis University, Budapest, Hungary, were born between 2017 and 2022. Clinical, laboratory, electrographic and neuroimaging data will be extracted from their medical records and will be evaluated retrospectively. Patients will be followed up to assess overall cognitive and language development between 4 and 8 years. The association between neonatal biomarkers and developmental language disorder (DLD) will be analysed with binary logistic regression models. Machine learning techniques will be used to develop predictive models for DLD. For modelling the longitudinal changes between early (2 years) and later (4-8 years) cognitive and language status, mixed effects models will be applied. Ethics and Dissemination: The protocol was approved by the National Centre for Public Health and Pharmacy (NNGYK/24844-9/2025) on 21 May 2025. Results of this study will be disseminated through multiple channels. We will publish the findings in international peer-reviewed scientific journals and present them at national and international conferences. Trial Registration Number: NCT07136636. (© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.) |
| Competing Interests: | Competing interests: None declared. |
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| Contributed Indexing: | Keywords: Developmental neurology & neurodisability; NEONATOLOGY; Paediatric neurology |
| Molecular Sequence: | ClinicalTrials.gov NCT07136636 |
| Entry Date(s): | Date Created: 20260810 Date Completed: 20260810 Latest Revision: 20260923 |
| Update Code: | 20260923 |
| PubMed Central ID: | PMC13475074 |
| DOI: | 10.1136/bmjopen-2026-120474 |
| PMID: | 42575547 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 2044-6055 |
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| DOI: | 10.1136/bmjopen-2026-120474 |