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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02883816

Enrollment

Registered

2016-08-30

Start date

2008-08-31

Completion date

2014-01-31

Last updated

2016-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

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.

Interventions

OTHERassessment of lung function

measurement of lung volumes and flow rates of bronchial

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Weeks to 14 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from respiratory function at 7 months and 11 months	7 months and 11 months	measurement of lung volumes and flow rates of bronchial

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026