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临床试验/NCT01895998
NCT01895998已完成1 期

Quantifying the Presence of Lung Disease and Pulmonary Hypertension in Children With Sickle Cell Disease

Duke University2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2013年8月最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
5
试验地点
2
主要终点
Presence of obstructive or restrictive lung disease

研究概览

简要总结

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 and/or cardiologist for monitoring, treatment and ongoing care.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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)
  • established patients within the Duke Pediatric Sickle Cell Clinic.
  • Subjects must have been full-term at birth
  • any race or gender

排除标准

  • significant chromosomal/congenital anomalies
  • hemodynamically significant congenital heart disease (arrhythmia requiring medication, defects with chronic hypoxia, single ventricle physiology, heart failure)
  • any child within 3 weeks of a respiratory tract infection, an asthma attack, an episode of ACS or of a vaso-occlusive or hemolytic crisis.

结局指标

主要结局

Presence of obstructive or restrictive lung disease

时间窗: 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.

次要结局

  • Presence of pulmonary hypertension(one testing session- approximately 15 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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