Acute Respiratory Distress SyndromeNCT01435889
Long Term (1 Year) Respiratory Sequelae in Children Surviving an Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome, run by University Hospital, Lille at 5 sites in 2 countries.
Trial summary
The purpose of this study is to assess long term (1 year) respiratory sequelae in children surviving an acute respiratory distress syndrome Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 38 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jun 2006to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: children hospitalised in PICU with ARDS and surviving 1 year after the acute phase
Who may be able to join
- children surviving to an acute respiratory distress syndrome and alive 1 year after discharge from the PICU
Who cannot join
- children suffering from neuromuscular disease
- children presenting symptoms of chronic respiratory disease before ARDS
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France4 sites
Hôpital Jeanne de Flandre, Centre Hospitalier Régional et Universitaire de Lille
Lille, 59 037 Lille Cedex
Hôpital Trousseau, Assistance Publique Hôpitaux de Paris
Paris, 75 571 Paris Cedex 12
Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris
Paris, 75 935 Cedex 19
Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris
Paris, 75743 Paris Cedex 19
Belgium1 site
Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles,
Brussels, 1020
About this study
Official title: Long Term (1 Year) Respiratory Sequelae in Children Surviving Acute Respiratory Distress Syndrome
The purpose of this study is to assess long term (1 year) respiratory sequelae in children surviving an acute respiratory distress syndrome
Read the 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
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute respiratory distress syndrome, Children, Long term respiratory sequelae, Pulmonary function tests, Computed tomography, lung
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic lung compliance
Measured: 1 year +- 2 months after discharge from ICU
Secondary outcomes (8)
respiratory complaints (cough, wheeze,dypnea at rest on exertion, bronchitis, pneumonia
Measured: 1 year +- 2 months after discharge from ICU
extend of ground glass opacification (CT scan)
Measured: 1 year +- 2 months after discharge from ICU
extend of intense parenchymal opacification
Measured: 1 year +- 2 months after discharge from ICU
extend of reticular pattern
Measured: 1 year +- 2 months after discharge from ICU
extend of decreased attenuation due to emphysema
Measured: 1 year +- 2 months after discharge from ICU
extend of decreased attenuation attributable to small-airway disease
Measured: 1 year +- 2 months after discharge from ICU
carbon monoxide diffusing capacity
Measured: 1 year +- 2 months after discharge from ICU
Pulse oxymetry oxygen saturation at the end of a 6 min walk test
Measured: 1 year +- 2 months after discharge from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startJun 2006
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis Leclerc, MD, Study chair, University hospital of Lille , France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435889
- Sponsor's protocol ID
- PHRC 2005/R-1906
- Other IDs
- PHRC 2005/R-1906
- Status last verified
- Dec 2015
- First submitted
- 16 Sep 2011
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35986824
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term (1 Year) Respiratory Sequelae in Children Surviving Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01435889
- Acronym / sponsor ID
- PHRC 2005/R-1906
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute respiratory distress syndrome, Children, Long term respiratory sequelae, Pulmonary function tests, Computed tomography, lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children hospitalised in PICU with ARDS and surviving 1 year after the acute phase
Key inclusion criteria (1 listed)
- children surviving to an acute respiratory distress syndrome and alive 1 year after discharge from the PICU
Key exclusion criteria (2 listed)
- children suffering from neuromuscular disease
- children presenting symptoms of chronic respiratory disease before ARDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dynamic lung compliance
Time frame: 1 year +- 2 months after discharge from ICU
8 secondary outcomes
respiratory complaints (cough, wheeze,dypnea at rest on exertion, bronchitis, pneumonia
Time frame: 1 year +- 2 months after discharge from ICU
extend of ground glass opacification (CT scan)
Time frame: 1 year +- 2 months after discharge from ICU
extend of intense parenchymal opacification
Time frame: 1 year +- 2 months after discharge from ICU
extend of reticular pattern
Time frame: 1 year +- 2 months after discharge from ICU
extend of decreased attenuation due to emphysema
Time frame: 1 year +- 2 months after discharge from ICU
extend of decreased attenuation attributable to small-airway disease
Time frame: 1 year +- 2 months after discharge from ICU
carbon monoxide diffusing capacity
Time frame: 1 year +- 2 months after discharge from ICU
Pulse oxymetry oxygen saturation at the end of a 6 min walk test
Time frame: 1 year +- 2 months after discharge from ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 35986824Neve 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.
Related trials for Acute Respiratory Distress Syndrome
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
Active, not recruitingObservational study
Longitudinal Recovery Trajectories After an Acute Respiratory Distress Syndrome, a New Understanding
ARDS, ARDS Disease Progression
RecruitingObservational study
Respiratory Distress and Elective Cesarean Section at Term
Respiratory Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Leclerc, MD study chair
University hospital of Lille , France
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by University Hospital, Lille at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic lung compliance (time frame: 1 year +- 2 months after discharge from ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01435889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.