Long Term (1 Year) Respiratory Sequelae in Children Surviving an Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Long Term (1 Year) Respiratory Sequelae in Children Surviving Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435889
• Other study ID #: PHRC 2005/R-1906
• Secondary ID: PHRC 2005/R-1906
• Status: Completed
• Phase: N/A
• First received: September 16, 2011
• Last updated: December 1, 2015
• Start date: June 2006
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess long term (1 year) respiratory sequelae in children surviving an acute respiratory distress syndrome

Description:

The acute respiratory distress syndrome (ARDS) has a high mortality rate in children. Adverse long term sequelae, and in particular respiratory sequelae, have been described mainly in adults. Decrease in diffusing capacity, lung volume and exercise tolerance were observed. Lung function parameters improve during the follow-up until 6 month after discharge from the pediatric intensive care unit (PICU). After that, abnormalities in PFT are observed in a significant proportion of patients. Only two studies described long-term sequelae in children surviving to an ARDS and their results are conflicting. Two studies carried out in adults described the morphologic long-term sequelae by thoracic computed tomography. They showed reticular pattern with a striking anterior distribution in most patients evaluated more than 6 months after discharge from the PICU. There is, to our knowledge, no study describing morphologic pulmonary sequelae by thoracic computed tomography in children surviving to ARDS.

Respiratory assessment: respiratory sequelae in children surviving to the acute respiratory distress syndrome will be evaluated 1 year after discharge from the PICU. Assessment will include a clinical evaluation (respiratory history and physical examination), respiratory function tests and thoracic computed tomography

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles,	Brussels
France	Hôpital Jeanne de Flandre, Centre Hospitalier Régional et Universitaire de Lille	Lille
France	Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris	Paris
France	Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris	Paris
France	Hôpital Trousseau, Assistance Publique Hôpitaux de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic lung compliance		1 year +- 2 months after discharge from ICU	No
Secondary	respiratory complaints (cough, wheeze,dypnea at rest on exertion, bronchitis, pneumonia		1 year +- 2 months after discharge from ICU	No
Secondary	extend of ground glass opacification (CT scan)		1 year +- 2 months after discharge from ICU	No
Secondary	extend of intense parenchymal opacification		1 year +- 2 months after discharge from ICU	No
Secondary	extend of reticular pattern		1 year +- 2 months after discharge from ICU	No
Secondary	extend of decreased attenuation due to emphysema		1 year +- 2 months after discharge from ICU	No
Secondary	extend of decreased attenuation attributable to small-airway disease		1 year +- 2 months after discharge from ICU	No
Secondary	carbon monoxide diffusing capacity		1 year +- 2 months after discharge from ICU	No
Secondary	Pulse oxymetry oxygen saturation at the end of a 6 min walk test		1 year +- 2 months after discharge from ICU	No