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

University Hospital Center (CHU)

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Other: assessment of lung function

Study type: Interventional

Funder types: Other

Identifiers

NCT02883816

8229

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 8 to 14 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

cystic fibrosis

Experimental group

Description:

assessment of lung function in newborns screened for cystic fibrosis

Treatment:

Other: assessment of lung function