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The association of neonatal multimodal brain network response characteristics with linguistic developmental disorder and autism spectrum disorder

Predictive value of neonatal brain response characteristics in linguistic developmental disorder and autism spectrum disorder

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300069898
Enrollment
Unknown
Registered
2023-03-29
Start date
2023-04-01
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

linguistic developmental disorder and autism spectrum disorder

Interventions

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: PART 1 1) Experimental group: 1.Informed consent of legal guardians; 2.Presence of high-risk factors for brain injury (including but not limited to prematurity, intrauterine distress, amniotic fluid III degree, neonatal asphyxia, neonatal sepsis, severe hyperbilirubinemia) or family history of language developmental disorders and autism spectrum or inherited metabolic disease; 3.Quiet during cerebral oxygen detection, near-infrared brain function imaging, and EEG detection; 4.Diagnosis of language developmental disorder or autism spectrum disorder; 5.Meeting the above criteria and meeting the exclusion criteria described below, the first 30 children diagnosed were enrolled in the experimental group according to chronological order. 2) Control group 1: 1-3. same as the experimental group; 4. Exclusion of language developmental disorders or autism spectrum disorders; 5. Eligible for the above criteria and meeting the exclusion criteria described below, the first 30 children with an exclusion diagnosis were admitted to control group 1 chronologically. 3) Control group 2: 1. Informed consent of legal guardians; 2. absence of risk factors for brain injury (including but not limited to prematurity, intrauterine distress, amniotic fluid III degree, neonatal asphyxia, neonatal sepsis, severe hyperbilirubinemia); 3. No family history of language developmental disorders and autism spectrum, no family history of inherited metabolic diseases; 4. Quiet during cerebral oxygen detection, near-infrared brain function imaging, and EEG detection; 5 Meeting the above criteria and meeting the exclusion criteria described below, the first 30 children with an exclusion diagnosis were enrolled in control group 2 chronologically. PART 2 1 Informed consent of the legal guardian; 2 Exist of the family history of high-risk factors for brain injury (including but not limited to prematurity, intrauterine distress, amniotic fluid III degree, neonatal asphyxia, neonatal sepsis, severe hyperbilirubinemia) or language developmental disorders and autism spectrum diseases or inherited metabolic diseases; 3 Keep quiet during cerebral oxygen detection, near-infrared brain function imaging, and EEG detection;

Exclusion criteria

Exclusion criteria: PART 1 1) Case group and control group 1: 1. Time to survive for all causes< 3 years; 2. social factors abandon treatment; 3. Application of sedative drugs within 48 hours before enrollment affects test results; 4. Hearing screening failed; 5. Children with predisposition to disease up to 3 years of age who cannot definitively exclude or diagnose language developmental disorders or autism spectrum disorders. 2) Control group 2: 1. Survival time < 3 years of age for various reasons, or growing neurologically-related diseases with no onset in the neonatal period; 2. social factors abandon treatment; 3. Application of sedative drugs within 48 hours before enrollment affects test results; 4. Hearing screening failed; 5. Children with predisposition to disease up to 3 years of age who cannot exclude or identify disorders of language development or autism spectrum disorders. PART 2 1 Died before < 3 years of age for any reason; 2 Discontinuation of treatment for social factors; 3 Application of sedative drugs may affect test results within 48 hours before enrollment ; 4 Failed the hearing screening.

Design outcomes

Primary

MeasureTime frame
Brain response characteristics of speech;Brain response characteristics of phonology;Sensitivity;specificity;

Countries

China

Contacts

Public ContactXinlin Hou

Peking University First Hospital

houxinlin66@163.com+86 135 5229 6675

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026