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Impact of Early Lung Physiology, Viral Infections and the Microbiota on the Development and Progression of Lung Disease in Children With Cystic Fibrosis (SCILD)

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ClinicalTrials.gov Identifier: NCT04026360
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : November 4, 2020
Sponsor:
Collaborators:
University Children's Hospital, Zurich
Centre Hospitalier Universitaire Vaudois
Kantonsspital Aarau
University Children's Hospital Basel
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
This study collects data on microbiological factors and lung function parameters (e.g. spirometry, body plethysmography, lung-MRI) to assess their interaction on the lung growth and lung development of infants and children with Cystic Fibrosis (CF).

Condition or disease Intervention/treatment
Confirmed Diagnosis of Cystic Fibrosis Other: no intervention

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Early Lung Physiology, Viral Infections and the Microbiota on the Development and Progression of Lung Disease in Children With Cystic Fibrosis
Actual Study Start Date : July 1, 2011
Estimated Primary Completion Date : August 31, 2050
Estimated Study Completion Date : December 31, 2050

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Multiple Breath Washout [ Time Frame: Every third year from the age of 4-8 weeks/1 year till 18 years. ]
    Longitudinal assessment of lung volume and ventilation inhomogeneity

  2. Spirometry [ Time Frame: Every third year from the age of 4-8 weeks/1 year till 18 years. ]
    Longitudinal assessment of long volumes.

  3. Body plethysmography [ Time Frame: Every third year from the age of 4-8 weeks/1 year till 18 years. ]
    Longitudinal assessment of ventilation inhomogeneity.

  4. Magnetic Resonance Imaging (MRI) [ Time Frame: At the age of 4-8 weeks, 1, 3, 6, 9, 12, 15 and 18 years ]
    Longitudinal assessment of regional lung perfusion and ventilation

  5. Nasal swabs [ Time Frame: At the age of 4-8 weeks, 1, 3, 6, 9, 12, 15 and 18 years ]
    Longitudinal assessment of viral and bacterial colonization of the nasal swab

  6. Weekly swabs [ Time Frame: Weekly from the visit at the age of 4-8 weeks till the age of 1 year ]
    Respiratory virus and bacterial diagnostic

  7. Swabs during respiratory infection [ Time Frame: From the visit at the age of 4-8 weeks till the age of 1 year ]
    Respiratory viruses and Bacteria, changes of the microbial flora

  8. Routine swabs in CF [ Time Frame: At the age of 4-8 weeks, 1 year and at each 3-monthly clinic visit during the age of 3, 6, 9, 12, 15 and 18 years ]
    Longitudinal assessment of bacterial changes, changes of the resistome (genes conferring antibiotic resistance) and the changes of the microbial flora


Secondary Outcome Measures :
  1. Respiratory Rate (RR) [ Time Frame: From the visit at the age of 4-8 weeks till the age of 1 year ]
    The number of breaths over 60 seconds

  2. Sweat test [ Time Frame: At the age of 3, 6, 9, 12, 15 and 18 years ]
    Sweat Chloride concentration


Biospecimen Retention:   Samples With DNA
Oropharyngeal swabs


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cystic Fibrosis Patients
Criteria

Inclusion Criteria:

  • Infants with a confirmed diagnosis of CF by NBS
  • Age <=18 years
  • Written informed consent by patient and/or parent

Exclusion Criteria:

  • Need for respiratory support for more than three days
  • Severe malformations or known diseases other than CF
  • Maternal drug abuse
  • Known severe maternal disease
  • Severe Problems of communication
  • Pacemaker, continuous glucose monitor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026360


Contacts
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Contact: Philipp Latzin, MD PhD 0041 31 632 94 93 philipp.latzin@insel.ch

Locations
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Switzerland
University Children's Hospital Bern Recruiting
Bern, Switzerland, 3010
Contact: Philipp Latzin, MD PhD    0041 31 632 94 93    philipp.latzin@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
University Children's Hospital, Zurich
Centre Hospitalier Universitaire Vaudois
Kantonsspital Aarau
University Children's Hospital Basel
Investigators
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Principal Investigator: Philipp Latzin, MD PhD University Children's Hospital Bern
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04026360    
Other Study ID Numbers: SCILD
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Infants
Cystic Fibrosis
Inflammation
Microbiome
Airway growth
Airway development
Genetic predisposition
Tobacco
Additional relevant MeSH terms:
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Virus Diseases
Cystic Fibrosis
Lung Diseases
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases