Quantifying the Presence of Lung Disease and Pulmonary Hypertension in Children With Sickle Cell Disease
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ClinicalTrials.gov Identifier: NCT01895998 |
Recruitment Status :
Completed
First Posted : July 11, 2013
Last Update Posted : December 3, 2014
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Sponsor:
Duke University
Information provided by (Responsible Party):
Duke University
Tracking Information | ||||
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First Submitted Date ICMJE | July 8, 2013 | |||
First Posted Date ICMJE | July 11, 2013 | |||
Last Update Posted Date | December 3, 2014 | |||
Study Start Date ICMJE | August 2013 | |||
Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Presence of obstructive or restrictive lung disease [ Time Frame: One testing session- approximately 3 hours total ] Obstructive lung disease will be defined as forced expiratory volume in 1 second (FEV1), or forced vital capacity (FVC) < 80% predicted based on normative data for age, sex, height, weight and race. Restrictive lung disease will be defined as total lung capacity (TLC) <80% predicted based on normative data for age, sex, height, weight and race.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Presence of pulmonary hypertension [ Time Frame: one testing session- approximately 15 minutes ] Pulmonary hypertension will be defined as a tricuspid regurgitation (TR) jet gradient that predicts a pulmonary artery (PA) systolic pressure greater than half of the systemic systolic pressure.
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Quantifying the Presence of Lung Disease and Pulmonary Hypertension in Children With Sickle Cell Disease | |||
Official Title ICMJE | Quantifying the Presence of Lung Disease and Pulmonary Hypertension in Children With Sickle Cell Disease | |||
Brief Summary | The proposed research study is a cross-sectional study enrolling young children with sickle cell disease between 5 and 12 years of age. They will be screened as outpatients for consent to perform pulmonary function testing (PFT) and echocardiography. In addition, the degree of bronchodilator response will be assessed at each session. To estimate presence of pulmonary hypertension, echocardiography will be performed at the time of PFT measures. Study Design:
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Sickle Cell Disease | |||
Intervention ICMJE | Drug: Albuterol
This medication will be used as routine part of pulmonary function testing to assess for airway hyperreactivity. This is routinely done in a clinical capacity for pediatric patients with various pulmonary disease processes.
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
5 | |||
Original Estimated Enrollment ICMJE |
32 | |||
Actual Study Completion Date ICMJE | April 2014 | |||
Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 5 Years to 12 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01895998 | |||
Other Study ID Numbers ICMJE | Pro00040933 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Duke University | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Duke University | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Duke University | |||
Verification Date | December 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |