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

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT01435889

Collaborator

(none)

Enrollment

Locations

100

Duration (Months)

7.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

38 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

respiratory complaints (cough, wheeze,dypnea at rest on exertion, bronchitis, pneumonia [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]
extend of decreased attenuation attributable to small-airway disease [1 year +- 2 months after discharge from ICU]
carbon monoxide diffusing capacity [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles,	Brussels	Belgium	1020
2	Hôpital Jeanne de Flandre, Centre Hospitalier Régional et Universitaire de Lille	Lille	France	59 037 Lille Cedex
3	Hôpital Trousseau, Assistance Publique Hôpitaux de Paris	Paris	France	75 571 Paris Cedex 12
4	Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris	Paris	France	75 935 Cedex 19
5	Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris	Paris	France	75743 Paris Cedex 19