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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

8 week–14 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

assessment of lung function

Other

measurement of lung volumes and flow rates of bronchial

Primary outcomes

Change from respiratory function at 7 months and 11 months

Time frame: 7 months and 11 months

measurement of lung volumes and flow rates of bronchial

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2014
Study completion: 2014
First posted: Aug 30, 2016
Registry last updated: Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed