Clinical trial NCT01435889: Long Term (1 Year) Respiratory Sequelae in Children Surviving an Acute Respiratory Distress Syndrome
Official title: Long Term (1 Year) Respiratory Sequelae in Children Surviving Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute respiratory distress syndrome
Children
Long term respiratory sequelae
Pulmonary function tests
Computed tomography, lung
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2011-09-19
Enrollment: 38
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children hospitalised in PICU with ARDS and surviving 1 year after the acute phase

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

Eligibility 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

Primary outcomes:
measure: Dynamic lung compliance
timeFrame: 1 year +- 2 months after discharge from ICU
Secondary outcomes:
measure: respiratory complaints (cough, wheeze,dypnea at rest on exertion, bronchitis, pneumonia
timeFrame: 1 year +- 2 months after discharge from ICU
measure: extend of ground glass opacification (CT scan)
timeFrame: 1 year +- 2 months after discharge from ICU
measure: extend of intense parenchymal opacification
timeFrame: 1 year +- 2 months after discharge from ICU
measure: extend of reticular pattern
timeFrame: 1 year +- 2 months after discharge from ICU
measure: extend of decreased attenuation due to emphysema
timeFrame: 1 year +- 2 months after discharge from ICU
measure: extend of decreased attenuation attributable to small-airway disease
timeFrame: 1 year +- 2 months after discharge from ICU
measure: carbon monoxide diffusing capacity
timeFrame: 1 year +- 2 months after discharge from ICU
measure: Pulse oxymetry oxygen saturation at the end of a 6 min walk test
timeFrame: 1 year +- 2 months after discharge from ICU
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles,
city: Lille
country: France
facility: Hôpital Jeanne de Flandre, Centre Hospitalier Régional et Universitaire de Lille
city: Paris
country: France
facility: Hôpital Trousseau, Assistance Publique Hôpitaux de Paris
city: Paris
country: France
facility: Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris
Study officials:
affiliation: University hospital of Lille , France
name: Francis Leclerc, MD
role: STUDY_CHAIR
References:
citation: Neve V, Sadik A, Petyt L, Dauger S, Kheniche A, Denjean A, Leger PL, Chalard F, Boule M, Javouhey E, Reix P, Canterino I, Deken V, Matran R, Leteurtre S, Leclerc F. Whole pulmonary assessment 1 year after paediatric acute respiratory distress syndrome: prospective multicentre study. Ann Intensive Care. 2022 Aug 20;12(1):79. doi: 10.1186/s13613-022-01050-4.