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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883816
• Other study ID #: 8229
• Status: Completed
• Phase: N/A
• First received: August 9, 2016
• Last updated: August 24, 2016
• Start date: August 2008
• Est. completion date: January 2014

Study information

• Verified date: August 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Weeks to 14 Weeks

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Inflammation

Intervention

Other:
• assessment of lung function
measurement of lung volumes and flow rates of bronchial

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from respiratory function at 7 months and 11 months	measurement of lung volumes and flow rates of bronchial	7 months and 11 months	No