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

University Hospital, Montpellier52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

assessment of lung functionOTHER

measurement of lung volumes and flow rates of bronchial

Eligibility

Sex: ALLMin age: 8 WeeksMax age: 14 Weeks

Medical Language ↔ Plain English

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

Locations (1)

CHU Montpellier

Montpellier, France

Outcomes

Primary Outcomes

Change from respiratory function at 7 months and 11 months

measurement of lung volumes and flow rates of bronchial

Time frame: 7 months and 11 months

Data from ClinicalTrials.gov

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