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Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT02883816
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

The main objective of this study is to show that there is a concordance between lung disease at 13 months and the existing 9 weeks in newborn babies with cystic fibrosis asymptomatically.

This will identify at the first examination at 8 weeks, newborns who have the most impaired lung function at 13 months. To meet this objective an assessment of their lung function at 9 weeks and 1 month will be performed in newborns diagnosed with cystic fibrosis.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: assessment of lung function Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis
Study Start Date : August 2008
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: cystic fibrosis
assessment of lung function in newborns screened for cystic fibrosis
Other: assessment of lung function
measurement of lung volumes and flow rates of bronchial




Primary Outcome Measures :
  1. Change from respiratory function at 7 months and 11 months [ Time Frame: 7 months and 11 months ]
    measurement of lung volumes and flow rates of bronchial



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Ages Eligible for Study:   8 Weeks to 14 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Infant aged 11 weeks

Exclusion criteria :

  • Gestational age lower than 35 weeks of gestation,
  • Background invasive mechanical ventilation in positive pressure
  • Documented -Obstructive Sleep Apnea, heart defect, neuromuscular disease

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): NCT02883816


Locations
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France
CHU Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02883816     History of Changes
Other Study ID Numbers: 8229
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Inflammation
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases