Long Term (1 Year) Respiratory Sequelae in Children Surviving an Acute Respiratory Distress Syndrome
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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 |
| Estimated Enrollment: | 45 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | October 2014 |
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 |
children hospitalised in PICU with ARDS and surviving 1 year after the acute phase
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| Contact: Francis Leclerc, MD | 33-3 20 44 68 84 | fleclerc@chru-lille.fr |
| Contact: Véronique Neve, MD | 33-3 20 44 59 82 | v-neve@chru-lille.fr |
| Belgium | |
| Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles, | Not yet recruiting |
| Brussels, Belgium, 1020 | |
| Principal Investigator: Dominique Biarent, MD | |
| Sub-Investigator: Pr Casimir, MD | |
| France | |
| Hôpital Jeanne de Flandre, Centre Hospitalier Régional et Universitaire de Lille | Recruiting |
| Lille, France, 59 037 Lille Cedex | |
| Contact: Francis Leclerc, MD 33-3 20 44 68 84 fleclerc@chru-lille.fr | |
| Contact: Véronique Nève, MD 33-3 20 44 59 82 v-neve@chru-lille.fr | |
| Sub-Investigator: Régis MATRAN, MD, Ph D | |
| Sub-Investigator: Christian Libersa, MD | |
| Sub-Investigator: Alain Duhamel, PhD | |
| Principal Investigator: Francis Leclerc, MD | |
| Sub-Investigator: Véronique Nève, MD | |
| Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris | Recruiting |
| Paris, France, 75 935 Cedex 19 | |
| Principal Investigator: Stephane Dauger, MD | |
| Sub-Investigator: André Deanjean, MD, PhD | |
| Sub-Investigator: Ahmed KHENICHE, MD | |
| Sub-Investigator: François CHALARD, MD | |
| Hôpital Trousseau, Assistance Publique Hôpitaux de Paris | Recruiting |
| Paris, France, 75 571 Paris Cedex 12 | |
| Principal Investigator: Sylvain Renolleau, MD | |
| Sub-Investigator: Michèle Boulé, MD, PhD | |
| Sub-Investigator: Hubert DUCOU LE POINTE, MD | |
| Sub-Investigator: Marion Lenoir, MD | |
| Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris | Recruiting |
| Paris, France, 75743 Paris Cedex 19 | |
| Principal Investigator: Philippe Hubert, MD | |
| Sub-Investigator: Muriel Lebourgeois, MD | |
| Sub-Investigator: Francis Brunelle, MD | |
| 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: | September 16, 2011 |
| 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:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |
ClinicalTrials.gov processed this record on May 21, 2013