NCT01435889

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

April 22, 2026

Status Verified

December 1, 2015

Enrollment Period

8.3 years

First QC Date

September 16, 2011

Last Update Submit

April 17, 2026

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute respiratory distress syndromeChildrenLong term respiratory sequelaePulmonary function testsComputed tomography, lung

Outcome Measures

Primary Outcomes (1)

  • Dynamic lung compliance

    1 year +- 2 months after discharge from ICU

Secondary Outcomes (8)

  • respiratory complaints (cough, wheeze,dypnea at rest on exertion, bronchitis, pneumonia

    1 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 opacification

    1 year +- 2 months after discharge from ICU

  • extend of reticular pattern

    1 year +- 2 months after discharge from ICU

  • extend of decreased attenuation due to emphysema

    1 year +- 2 months after discharge from ICU

  • +3 more secondary outcomes

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • children surviving to an acute respiratory distress syndrome and alive 1 year after discharge from the PICU

You may not qualify if:

  • children suffering from neuromuscular disease
  • children presenting symptoms of chronic respiratory disease before ARDS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles,

Brussels, 1020, Belgium

Location

Hôpital Jeanne de Flandre, Centre Hospitalier Régional et Universitaire de Lille

Lille, 59 037 Lille Cedex, France

Location

Hôpital Trousseau, Assistance Publique Hôpitaux de Paris

Paris, 75 571 Paris Cedex 12, France

Location

Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris

Paris, 75 935 Cedex 19, France

Location

Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris

Paris, 75743 Paris Cedex 19, France

Location

Related Publications (1)

  • 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.

    PMID: 35986824RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Francis Leclerc, MD

    University hospital of Lille , France

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2011

First Posted

September 19, 2011

Study Start

June 1, 2006

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

April 22, 2026

Record last verified: 2015-12

Locations

FR(4)BE(1)