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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01435889
Enrollment
38
Registered
2011-09-19
Start date
2006-06-01
Completion date
2014-10-01
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute respiratory distress syndrome, Children, Long term respiratory sequelae, Pulmonary function tests, Computed tomography, lung

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

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Dynamic lung compliance1 year +- 2 months after discharge from ICU

Secondary

MeasureTime frame
respiratory complaints (cough, wheeze,dypnea at rest on exertion, bronchitis, pneumonia1 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 opacification1 year +- 2 months after discharge from ICU
extend of reticular pattern1 year +- 2 months after discharge from ICU
extend of decreased attenuation due to emphysema1 year +- 2 months after discharge from ICU
extend of decreased attenuation attributable to small-airway disease1 year +- 2 months after discharge from ICU
carbon monoxide diffusing capacity1 year +- 2 months after discharge from ICU
Pulse oxymetry oxygen saturation at the end of a 6 min walk test1 year +- 2 months after discharge from ICU

Countries

Belgium, France

Contacts

STUDY_CHAIRFrancis Leclerc, MD

University hospital of Lille , France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026