Back to resultsEarly Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
assessment of lung function
Sponsored by
About this trial
This is an interventional diagnostic trial for Cystic Fibrosis
Eligibility 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
Sites / Locations
- CHU Montpellier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cystic fibrosis
Arm Description
assessment of lung function in newborns screened for cystic fibrosis
Outcomes
Primary Outcome Measures
Change from respiratory function at 7 months and 11 months
measurement of lung volumes and flow rates of bronchial
Secondary Outcome Measures
Full Information
NCT ID
NCT02883816
First Posted
August 9, 2016
Last Updated
August 24, 2016
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02883816
Brief Title
Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis
Official Title
Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cystic fibrosis
Arm Type
Experimental
Arm Description
assessment of lung function in newborns screened for cystic fibrosis
Intervention Type
Other
Intervention Name(s)
assessment of lung function
Intervention Description
measurement of lung volumes and flow rates of bronchial
Primary Outcome Measure Information:
Title
Change from respiratory function at 7 months and 11 months
Description
measurement of lung volumes and flow rates of bronchial
Time Frame
7 months and 11 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Weeks
Maximum Age & Unit of Time
14 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Learn more about this trial
Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis
We'll reach out to this number within 24 hrs