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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00560261
First received: November 16, 2007
Last updated: August 2, 2012
Last verified: July 2012

November 16, 2007
August 2, 2012
February 2008
February 2012   (final data collection date for primary outcome measure)
Study of lung capillary blood volume and alveolar membrane diffusing capacity using NO-CO method [ Time Frame: The day of the measure ] [ Designated as safety issue: Yes ]
Study of lung capillary blood volume and alveolar membrane diffusing capacity using NO-CO method [ Time Frame: The day of the measure ]
Complete list of historical versions of study NCT00560261 on ClinicalTrials.gov Archive Site
  • Respiratory physiopathology's study in sickle cell disease [ Time Frame: At the induction of the study ] [ Designated as safety issue: Yes ]
  • Valid alveolar membrane diffusing capacity using NO-CO in children with or without sickle cell disease [ Time Frame: At the induction of the study ] [ Designated as safety issue: Yes ]
  • Purpose respiratory function follow up in sickle cell disease child [ Time Frame: At the induction of the study ] [ Designated as safety issue: Yes ]
  • Find relationship between these vascular abnormalities and NO metabolism [ Time Frame: At the induction of the study ] [ Designated as safety issue: Yes ]
  • Respiratory physiopathology's study in sickle cell disease [ Time Frame: At the induction of the study ]
  • Valid alveolar membrane diffusing capacity using NO-CO in children with or without sickle cell disease [ Time Frame: At the induction of the study ]
  • Purpose respiratory function follow up in sickle cell disease child [ Time Frame: At the induction of the study ]
  • Find relationship between these vascular abnormalities and NO metabolism [ Time Frame: At the induction of the study ]
Not Provided
Not Provided
 
Evaluation of the Lung Capillary Blood Volume in Children With Sickle Cell Disease
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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Sickle Cell Disease
Other: NO-CO inhalation and expiration
NO-CO inhalation and expiration
Other Name: NO-CO inhalation and expiration
  • Experimental: 1:Children with sickle cell disease

    NO-CO inhalation and expiration:

    Children with sickle cell disease

    Intervention: Other: NO-CO inhalation and expiration
  • Active Comparator: 2: Healthy volunteers

    NO-CO inhalation and expiration:

    Healthy volunteers

    Intervention: Other: NO-CO inhalation and expiration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
6 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00560261
P061013, 2007-A00913-50
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Florence MISSUD, Md Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP