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Completed

NCT Number: NCT02032381

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

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.

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Key information

Conditions

Bone Marrow Transplant Infection Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchitis Chronic Respiratory Insufficiency Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Pulmonary Cytolytic Thrombi Respiratory Tract Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houdouin véronique

Paris, 75019, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • non exclusion criteria

Treatment and study plan

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

Other

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: RESPPEDHEM

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jan 10, 2014
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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