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

Completed

• Conditions: Acute Respiratory Distress Syndrome

• Registration Number: NCT01435889
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2011-09-16
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-19
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dynamic lung compliance	1 year +- 2 months after discharge from ICU

Secondary Outcome Measures

Name	Time	Method
respiratory complaints (cough, wheeze,dypnea at rest on exertion, bronchitis, pneumonia	1 year +- 2 months after discharge from ICU
carbon monoxide diffusing capacity	1 year +- 2 months after discharge from ICU
extend of decreased attenuation attributable to small-airway disease	1 year +- 2 months after discharge from ICU
extend of ground glass opacification (CT scan)	1 year +- 2 months after discharge from ICU
extend of intense parenchymal opacification	1 year +- 2 months after discharge from ICU
extend of reticular pattern	1 year +- 2 months after discharge from ICU
extend of decreased attenuation due to emphysema	1 year +- 2 months after discharge from ICU
Pulse oxymetry oxygen saturation at the end of a 6 min walk test	1 year +- 2 months after discharge from ICU

Trial Locations

Locations (5)

Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles,; 🇧🇪 Brussels, Belgium

Hôpital Jeanne de Flandre, Centre Hospitalier Régional et Universitaire de Lille; 🇫🇷 Lille, France

Hôpital Trousseau, Assistance Publique Hôpitaux de Paris; 🇫🇷 Paris, France

Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris; 🇫🇷 Paris, France

Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris; 🇫🇷 Paris, France