ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	14 December 2015
Main ID:	NCT01435889
Date of registration:	16/09/2011
Prospective Registration:	No
Primary sponsor:	University Hospital, Lille
Public title:	Long Term (1 Year) Respiratory Sequelae in Children Surviving an Acute Respiratory Distress Syndrome
Scientific title:	Long Term (1 Year) Respiratory Sequelae in Children Surviving Acute Respiratory Distress Syndrome
Date of first enrolment:	June 2006
Target sample size:	38
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01435889
Study type:	Observational
Study design:	Observational Model: Cohort, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
Belgium	France

Contacts

Name:	Francis Leclerc, MD
Address:
Telephone:
Email:
Affiliation:	University hospital of Lille , France

Key inclusion & exclusion criteria

Inclusion Criteria:

- children surviving to an acute respiratory distress syndrome and alive 1 year after
discharge from the PICU

Exclusion Criteria:

- children suffering from neuromuscular disease

- children presenting symptoms of chronic respiratory disease before ARDS

Age minimum: 1 Year
Age maximum: 16 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Respiratory Distress Syndrome

Intervention(s)

Primary Outcome(s)

Dynamic lung compliance [Time Frame: 1 year +- 2 months after discharge from ICU]

Secondary Outcome(s)

extend of reticular pattern [Time Frame: 1 year +- 2 months after discharge from ICU]

carbon monoxide diffusing capacity [Time Frame: 1 year +- 2 months after discharge from ICU]

extend of ground glass opacification (CT scan) [Time Frame: 1 year +- 2 months after discharge from ICU]

extend of decreased attenuation attributable to small-airway disease [Time Frame: 1 year +- 2 months after discharge from ICU]

Pulse oxymetry oxygen saturation at the end of a 6 min walk test [Time Frame: 1 year +- 2 months after discharge from ICU]

extend of decreased attenuation due to emphysema [Time Frame: 1 year +- 2 months after discharge from ICU]

extend of intense parenchymal opacification [Time Frame: 1 year +- 2 months after discharge from ICU]

respiratory complaints (cough, wheeze,dypnea at rest on exertion, bronchitis, pneumonia [Time Frame: 1 year +- 2 months after discharge from ICU]

Secondary ID(s)

PHRC 2005/R-1906

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.