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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01435889
First received: September 16, 2011
Last updated: June 17, 2015
Last verified: June 2015
  Purpose

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


Condition
Acute Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term (1 Year) Respiratory Sequelae in Children Surviving Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Dynamic lung compliance [ Time Frame: 1 year +- 2 months after discharge from ICU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • respiratory complaints (cough, wheeze,dypnea at rest on exertion, bronchitis, pneumonia [ Time Frame: 1 year +- 2 months after discharge from ICU ] [ Designated as safety issue: No ]
  • extend of ground glass opacification (CT scan) [ Time Frame: 1 year +- 2 months after discharge from ICU ] [ Designated as safety issue: No ]
  • extend of intense parenchymal opacification [ Time Frame: 1 year +- 2 months after discharge from ICU ] [ Designated as safety issue: No ]
  • extend of reticular pattern [ Time Frame: 1 year +- 2 months after discharge from ICU ] [ Designated as safety issue: No ]
  • extend of decreased attenuation due to emphysema [ Time Frame: 1 year +- 2 months after discharge from ICU ] [ Designated as safety issue: No ]
  • extend of decreased attenuation attributable to small-airway disease [ Time Frame: 1 year +- 2 months after discharge from ICU ] [ Designated as safety issue: No ]
  • carbon monoxide diffusing capacity [ Time Frame: 1 year +- 2 months after discharge from ICU ] [ Designated as safety issue: No ]
  • Pulse oxymetry oxygen saturation at the end of a 6 min walk test [ Time Frame: 1 year +- 2 months after discharge from ICU ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: June 2006
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

children hospitalised in PICU with ARDS and surviving 1 year after the acute phase

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435889

Locations
Belgium
Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles,
Brussels, Belgium, 1020
France
Hôpital Jeanne de Flandre, Centre Hospitalier Régional et Universitaire de Lille
Lille, France, 59 037 Lille Cedex
Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris
Paris, France, 75743 Paris Cedex 19
Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris
Paris, France, 75 935 Cedex 19
Hôpital Trousseau, Assistance Publique Hôpitaux de Paris
Paris, France, 75 571 Paris Cedex 12
Sponsors and Collaborators
University Hospital, Lille
Investigators
Study Chair: Francis Leclerc, MD University hospital of Lille , France
  More Information

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01435889     History of Changes
Other Study ID Numbers: PHRC 2005/R-1906, PHRC 2005/R-1906
Study First Received: September 16, 2011
Last Updated: June 17, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Lille:
Acute respiratory distress syndrome
Children
Long term respiratory sequelae
Pulmonary function tests
Computed tomography, lung

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 28, 2015