Ignite Creation Date:
2024-05-06 @ 1:47 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01895998
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2013-07-08
Brief Title:
Quantifying the Presence of Lung Disease and Pulmonary Hypertension in Children With Sickle Cell Disease
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Quantifying the Presence of Lung Disease and Pulmonary Hypertension in Children With Sickle Cell Disease
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1 Enroll children aged 5 to 12 years of age with sickle cell disease HbSS HbSC HbS beta plus thalassemia HbS beta zero thalassemia and HbS OArab who are established patients within the Duke Pediatric Sickle Cell Clinic
2 Perform a chart review of all enrolled subjects to obtain specific details regarding birth history nutritional status weight height family history sickle cell genotype parental smoking history recent laboratory parameters parental smoking history any concurrent conditions atopy asthma airway anomaly history of sickle cell complications and prescribed medications
3 Perform spirometry and plethysmography with the administration of albuterol
4 Before or after completion the PFT session the patient will have echocardiography in the PFT lab area
5 Using medical record information determine number of hospitalizations for any pulmonary symptoms indicative of acute chest syndrome ACS dyspnea fever wheezing hypoxia cough chest pain In addition we will track any respiratory or cardiac symptoms or therapies for each subject 6 years after enrollment up to age 18 years using the registry
6 As standard of care refer any child identified as having lung disease or pulmonary hypertension to a pediatric pulmonologist andor cardiologist for monitoring treatment and ongoing care
Study Design
1 Enroll children aged 5 to 12 years of age with sickle cell disease HbSS HbSC HbS beta plus thalassemia HbS beta zero thalassemia and HbS OArab who are established patients within the Duke Pediatric Sickle Cell Clinic
2 Perform a chart review of all enrolled subjects to obtain specific details regarding birth history nutritional status weight height family history sickle cell genotype parental smoking history recent laboratory parameters parental smoking history any concurrent conditions atopy asthma airway anomaly history of sickle cell complications and prescribed medications
3 Perform spirometry and plethysmography with the administration of albuterol
4 Before or after completion the PFT session the patient will have echocardiography in the PFT lab area
5 Using medical record information determine number of hospitalizations for any pulmonary symptoms indicative of acute chest syndrome ACS dyspnea fever wheezing hypoxia cough chest pain In addition we will track any respiratory or cardiac symptoms or therapies for each subject 6 years after enrollment up to age 18 years using the registry
6 As standard of care refer any child identified as having lung disease or pulmonary hypertension to a pediatric pulmonologist andor cardiologist for monitoring treatment and ongoing care
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None