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Completed

NCT Number: NCT00560261

Evaluation of the Lung Capillary Blood Volume in Children With Sickle Cell Disease

Sickle cell disease (SCD) is the most common inherited disease of the world affecting African and Caribbean populations. SCD is caused by the homozygous inheritance of the gene for sickle hemoglobin (HbS). Most patients with SCD develop abnormal pulmonary function characterized by airway obstruction, restrictive lung disease, abnormal diffusing capacity, hypoxemia and pulmonary hypertension In healthy subjects, lung capillary blood volume (Qc) and membrane diffusing capacity (Dm) can be accurately measured by the nitric oxide-carbon monoxide (NO-CO) method. We propose to study, for the first time, lung capillary blood volume and alveolar membrane diffusing capacity, using the NO-CO method, in children with SCD aged of at least 6 years Early determination of lung function and pulmonary circulation in children with SCD is very important, not only for the understanding of physiopathologic mechanisms of the disease but also for a better therapeutic management of these children.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hopital Robert DEBRE

Paris, 75019, France

About this study

We propose to study, for the first time, lung capillary blood volume and alveolar membrane diffusing capacity, using the NO-CO method, in children with SCD aged of at least 6 years. We will compare lung function and measurement of Qc and Dm in 2 groups of 120 subjects, one group of SCD children, and the other of normal children matched on age and ethnic origin. Measurement of lung capillary blood will be measured twice, to assess short term reproducibility. The measurement will be done in sitting position and lying down for one part of subjects, and at rest and during a moderate rectangular exercise for the other part of subjects. These different tests are designed to assess the physiological adaptation of pulmonary circulation in these two populations of children. Combined with complete lung function measurements, echocardiographic assessment of pulmonary hemodynamics, and measurement of exhaled nitric oxide, these evaluations will lead to a better understanding of pathophysiology of lung injury in SCD. The study will be completes at Robert Debré Hospital, in close collaboration with Sickle Cell Disease Center and Physiology Department. Children will be included after informed consent signed, as legally prescribed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children between 6 and 18 years
  • Sickle cell disease( SS,SC, SBETA O, SDpunjab) and control without sickle cell disease
  • Social insurance
  • Signed informed consent

Exclusion criteria

  • Respiratory disease other tha asthma
  • Cardiac disease
  • Encephalopathy
  • G6PD deficiency
  • Consent not signed

Treatment and study plan

NO-CO inhalation and expiration

Other

NO-CO inhalation and expiration

Primary outcomes

  1. Study of lung capillary blood volume and alveolar membrane diffusing capacity using NO-CO method

    Time frame: The day of the measure

Secondary outcomes

  1. Respiratory physiopathology's study in sickle cell disease

    Time frame: At the induction of the study

  2. Valid alveolar membrane diffusing capacity using NO-CO in children with or without sickle cell disease

    Time frame: At the induction of the study

  3. Purpose respiratory function follow up in sickle cell disease child

    Time frame: At the induction of the study

  4. Find relationship between these vascular abnormalities and NO metabolism

    Time frame: At the induction of the study

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: VOLCADREP

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 19, 2007
Registry last updated
Feb 3, 2023

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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