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临床试验/NCT03134300
NCT03134300已完成不适用

Cytokine Persistence as a Marker of Inflammation in the at Risk, Low Socioeconomic Status Pediatric Population

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年1月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Increased cytokines in low SES group

研究概览

简要总结

The investigators wish to study the role of persistent markers of inflammation in executive function in young children during critical periods of synaptogenesis (ages 2-3). While the role of markers of inflammation have been validated in the pathogenesis in multiple disorders in the adult population, their study in pediatrics is limited. The investigators therefore propose that demonstration of persistent cytokine inflammatory markers in this preliminary study will allow larger studies to proceed.

详细描述

Obstructive sleep apnea (OSA) is a common multisystem disorder, affecting up to 10% of the pediatric population. There is scant data about OSA and adenotonsillectomy (AT) outcomes in the very young (ages 1-3). Young children with moderate/severe OSA are often underprivileged, low socioeconomic status (SES) minorities with limited access to care. Further complicating the problem is that African American children may suffer a higher preoperative and post-AT burden of disease, with greater negative consequences to these vulnerable children. Up to 75% of children with OSA continue to have sequelae of the disease post-AT. These include poor school performance, delayed speech, inattention, and long term neurocognitive dysfunction. It has been demonstrated that younger patients (below the age of 3) have larger tonsils and stunted growth on presentation for AT. More telling is that younger children face greater morbidity from the procedure, including respiratory complications, postoperative bleeding, and perioperative anoxic/hypoxic injury as validated by multiple studies. A recent study studied watchful waiting versus early AT in two groups of patients aged 5-9 without severe OSA. The findings indicated that early AT improved respiratory and quality of life indices without corresponding improvement in attention or cognitive function as assessed by neuropsychological testing 7 months post intervention. So it leads to the further question of whether children with severe OSA truly benefit from the procedure at all, and whether there maybe a trend towards harm. In this particular scenario, the investigators are hypothesizing that serum based biomarkers in the form of cytokines are of significant diagnostic benefit in demonstrating ongoing inflammation.

Therefore, the surgical stimulus and consequent stress response in the form of centrally mediated cytokines and inflammatory mediators demands study. These has been well analyzed with adult acute and chronic pain, and have been associated with neurocognitive impairment, but have not been studied as a neurocognitive biomarker in the pediatric population. Children from lower SES, with less stable social environments, or other cultural/linguistic barriers are higher risk and urgently require study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • OSA for adenotonsillectomy -

排除标准

  • 未提供

研究组 & 干预措施

Low SES

Active Comparator

干预措施: Cytokine from blood (Diagnostic Test)

Normal/high SES

Placebo Comparator

干预措施: Cytokine from blood (Diagnostic Test)

结局指标

主要结局

Increased cytokines in low SES group

时间窗: 3 weeks post operative

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arvind Chandrakantan

Assistant Professor of Anesthesiology & Pediatrics

Baylor College of Medicine

研究点 (2)

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