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| Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00560261 |
Purpose
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.
| Condition | Intervention | Phase |
|
Sickle Cell Disease |
Other: NO-CO inhalation and expiration |
Phase III |
| Genetics Home Reference related topics: | sickle cell disease |
| MedlinePlus related topics: | Sickle Cell Anemia |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | Evaluation of the Lung Capillary Blood Volume in Children With Sickle Cell Disease |
| Estimated Enrollment: | 240 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Children with sickle cell disease
|
Other: NO-CO inhalation and expiration
NO-CO inhalation and expiration
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2: Active Comparator
Healthy volunteers
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Other: NO-CO inhalation and expiration
NO-CO inhalation and expiration
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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.
Eligibility
| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Florence MISSUD, Md | 01 40 03 23 52 | florence.missud@rdb.aphp.fr |
| France | |||||
| Hopital Robert DEBRE | Recruiting | ||||
| Paris, France, 75019 | |||||
| Contact: Florence MISSUD, Md 01 40 03 23 52 florence.missud@rdb.aphp.fr | |||||
| Contact: Florence MISSUD, Md 01 40 03 23 52 florence.missud@rdb.aphp.fr | |||||
| Principal Investigator: Florence MISSUD, Md | |||||
| Assistance Publique - Hôpitaux de Paris |
| Principal Investigator: | Florence MISSUD, Md | Assistance Publique - Hôpitaux de Paris |
More Information
| Responsible Party: | Department Clinical Research of Developpement ( Amel Ouslimani ) |
| Study ID Numbers: | P061013, ID-RCB-2007-A00913-50 |
| First Received: | November 16, 2007 |
| Last Updated: | March 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00560261 |
| Health Authority: | France: Ministry of Health |
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