LUCIND Study: Characterization of structural lung disease in children and adolescents with severe neurological diseases

LUCIND Study: Characterization of structural lung disease in children and adolescents with severe neurological diseases - LUCIND - Lung Comorbidity In Neurological Diseases

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038747

Enrollment

150

Registered

2025-12-15

Start date

2025-02-19

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Secondary chronic lung disease in children with severe underlying neurological diseases.

Interventions

Group 1: Population: Children and adolescents (5–18 years) with severe neurological diseases and tracheostomy. Intervention/Examination: Performance of a single native ultra-low-dose photon-counting C

Eligibility

Sex/Gender

All

Age

5 Years to 18 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of a severe neurological disease (defined as CNS or neuromuscular disorder with severe motor/cognitive impairment) - Assignable to one of three study groups: (1) Tracheostomy, (2) Dysphagia, (3) No Dysphagia - Written informed consent obtained from patient and/or legal guardians

Exclusion criteria

Exclusion criteria: - Known primary pulmonary disease - Acute severe illness - Pregnancy - Increased individual susceptibility to ionizing radiation - Lack of informed consent

Design outcomes

Primary

Measure	Time frame
WHAT: Prevalence and severity of chronic structural lung abnormalities (defined as bronchiectasis, bronchial wall thickening, consolidations). WHEN: At a single time point upon enrollment (cross-sectional design). HOW: Performance of an ultra-low-dose photon-counting computed tomography (PCCT) of the chest in inspiration. Assessment is performed in a blinded manner by three experienced radiologists using standardized criteria.	—

Measure

Time frame

WHAT: Prevalence and severity of chronic structural lung abnormalities (defined as bronchiectasis, bronchial wall thickening, consolidations). WHEN: At a single time point upon enrollment (cross-sectional design). HOW: Performance of an ultra-low-dose photon-counting computed tomography (PCCT) of the chest in inspiration. Assessment is performed in a blinded manner by three experienced radiologists using standardized criteria.

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Secondary

Measure	Time frame
Clinical characteristics and respiratory disease burden: Assessment of infection frequency, antibiotic use, hospitalizations, and respiratory symptoms via standardized questionnaire and medical record review. Bulbar function and aspiration risk: Assessment of swallowing safety using the Pediatric Functional Oral Intake Scale (p-FOIS) and drooling severity using the Drooling Frequency and Severity Scale (DFSF), alongside logopedic evaluation (at enrollment). Microbiology: Detection of bacterial airway colonization (e.g., Pseudomonas aeruginosa) via throat swab or sputum analysis (at enrollment). Pulmonary function: Measurement of FVC, FEV1, and Peak Cough Flow (PCF) in cooperative patients (at enrollment). Correlation: Investigation of the association between radiological PCCT findings and the clinical/functional parameters listed above.	—

Measure

Time frame

Clinical characteristics and respiratory disease burden: Assessment of infection frequency, antibiotic use, hospitalizations, and respiratory symptoms via standardized questionnaire and medical record review. Bulbar function and aspiration risk: Assessment of swallowing safety using the Pediatric Functional Oral Intake Scale (p-FOIS) and drooling severity using the Drooling Frequency and Severity Scale (DFSF), alongside logopedic evaluation (at enrollment). Microbiology: Detection of bacterial airway colonization (e.g., Pseudomonas aeruginosa) via throat swab or sputum analysis (at enrollment). Pulmonary function: Measurement of FVC, FEV1, and Peak Cough Flow (PCF) in cooperative patients (at enrollment). Correlation: Investigation of the association between radiological PCCT findings and the clinical/functional parameters listed above.

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Countries

Germany

Contacts

Public ContactDaniel Alexander Frederik Bernard

Universitätsklinikum Essen

daniel.bernard@uk-essen.de+492017230

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jul 16, 2026