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CompletedNCT02032381RESPPEDHEMUpdated Apr 29, 2020

Prospective Study of Belated Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.

An interventional study of late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells. in Bone Marrow Transplant Infection, Bronchiolitis Obliterans and Chronic Respiratory Insufficiency, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-04-29.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study summary

Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC), to evaluate the prevalence and course of PFT abnormalities before and after transplant, and to detect risk factor for PC.

Read the detailed description

It's a multicenter prospective study in France. All children under 18 years are included, just before the HSCT. The functional test before the HSCT at 6, 12, 18, 24, 30 and 36 months will be collected and a cardiopulmonary exercise test is done one and three years after the HSCT. Thoracic tomodensitometry is done before the HCT and after at 6, 12, 24 and 36 months.

All data will be collected upon the HSCT, the infections before and after the HSCT, the respiratory symptoms, and the treatment. Bronchia alveolar lavage and serum will be collected and frozen during the study.

The inclusion will be done during two years and children will be following during three years.

The purpose is to evaluate the prevalence, the course of PFT abnormalities before and after transplant, and to detect risk factor for PC.

02

Conditions studied

  • Bone Marrow Transplant Infection
  • Bronchiolitis Obliterans
  • Chronic Respiratory Insufficiency
  • Organizing Pneumonia
  • Pulmonary Cytolytic Thrombi

Keywords

  • non infectious pulmonary complications after hematopoietic cell transplant
  • functional respiratory test and exercise test
  • thoracic tomodensitometry
03

In context

Bronchiolitis

360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.

This study's enrollment of 300 is above the median of 80 across 249 interventional studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age: from birth to 18 years
  • Patient to be treated by allogeneic hematopoietic stem cell - Parents who have given their signed consent for the study
  • Affiliation to a social security scheme

Exclusion criteria

Exclusion Criteria:

  • non exclusion criteria
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Other
    allogeneic hematopoietic stem cell

    The eligible population for this study will consist of all children under 18 years who received allogeneic hematopoietic stem cell and evaluate of late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.

    Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.

Interventions

  • Otherlate pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.
06

What researchers measure

Primary outcomes

  1. Presence of belated non-infectious pulmonary complications

    Time frame: 3 years

Secondary outcomes

  1. Presence of risk factors for belated non-infectious pulmonary complications

    Time frame: 3 years

  2. Survival three years

    Time frame: 3 years

  3. Severity of respiratory disease

    Time frame: 3 years

07

Study locations

1 site
  • Houdouin véronique
    Paris, 75019, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02032381
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jan 10, 2014
Start date
Jan 2014
Primary completion
Mar 30, 2020
Completion
Mar 30, 2020
Last update
Apr 29, 2020

Study contacts

Houdouin Véronique, MD PHD
principal investigator · APHP

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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