NCT02883816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

5.4 years

First QC Date

August 9, 2016

Last Update Submit

August 24, 2016

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Change from respiratory function at 7 months and 11 months

    measurement of lung volumes and flow rates of bronchial

    7 months and 11 months

Study Arms (1)

cystic fibrosis

EXPERIMENTAL

assessment of lung function in newborns screened for cystic fibrosis

Other: assessment of lung function

Interventions

assessment of lung functionOTHER

measurement of lung volumes and flow rates of bronchial

cystic fibrosis

Eligibility Criteria

Age8 Weeks - 14 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infant aged 11 weeks

You may not qualify if:

  • Gestational age lower than 35 weeks of gestation,
  • Background invasive mechanical ventilation in positive pressure
  • Documented -Obstructive Sleep Apnea, heart defect, neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 30, 2016

Study Start

August 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations

FR(1)