NCT04026360

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
299mo left

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Jul 2011Dec 2050

Study Start

First participant enrolled

July 1, 2011

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
31.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2050

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2050

Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

39.2 years

First QC Date

May 14, 2019

Last Update Submit

November 3, 2020

Conditions

Confirmed Diagnosis of Cystic Fibrosis

Keywords

InfantsCystic FibrosisInflammationMicrobiomeAirway growthAirway developmentGenetic predispositionTobacco

Outcome Measures

Primary Outcomes (8)

  • Multiple Breath Washout

    Longitudinal assessment of lung volume and ventilation inhomogeneity

    Every third year from the age of 4-8 weeks/1 year till 18 years.

  • Spirometry

    Longitudinal assessment of long volumes.

    Every third year from the age of 4-8 weeks/1 year till 18 years.

  • Body plethysmography

    Longitudinal assessment of ventilation inhomogeneity.

    Every third year from the age of 4-8 weeks/1 year till 18 years.

  • Magnetic Resonance Imaging (MRI)

    Longitudinal assessment of regional lung perfusion and ventilation

    At the age of 4-8 weeks, 1, 3, 6, 9, 12, 15 and 18 years

  • Nasal swabs

    Longitudinal assessment of viral and bacterial colonization of the nasal swab

    At the age of 4-8 weeks, 1, 3, 6, 9, 12, 15 and 18 years

  • Weekly swabs

    Respiratory virus and bacterial diagnostic

    Weekly from the visit at the age of 4-8 weeks till the age of 1 year

  • Swabs during respiratory infection

    Respiratory viruses and Bacteria, changes of the microbial flora

    From the visit at the age of 4-8 weeks till the age of 1 year

  • Routine swabs in CF

    Longitudinal assessment of bacterial changes, changes of the resistome (genes conferring antibiotic resistance) and the changes of the microbial flora

    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

Secondary Outcomes (2)

  • Respiratory Rate (RR)

    From the visit at the age of 4-8 weeks till the age of 1 year

  • Sweat test

    At the age of 3, 6, 9, 12, 15 and 18 years

Interventions

no interventionOTHER

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Cystic Fibrosis Patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Bern

Bern, 3010, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Oropharyngeal swabs

MeSH Terms

Conditions

Cystic FibrosisInflammationGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease SusceptibilityDisease Attributes

Study Officials

  • Philipp Latzin, MD PhD

    University Children's Hospital Bern

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Latzin, MD PhD

CONTACT

0041 31 632 94 93philipp.latzin@insel.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2019

First Posted

July 19, 2019

Study Start

July 1, 2011

Primary Completion (Estimated)

August 31, 2050

Study Completion (Estimated)

December 31, 2050

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

CH(1)