Prevalence of High Blood Pressure in Paediatric Patients With Sleep Disorder Breathing. Reversibility After Treatment (The Kids TRIAL STUDY).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 286
- 试验地点
- 2
- 主要终点
- Mean systolic and diastolic blood pressure
研究概览
简要总结
There are data supporting a possible increase in the prevalence of High Blood Pressure (HBP) in pediatric patients with Sleep Disorder Breathing (SDB). Adeno-tonsillectomy has proven to be an effective treatment in the correction of nocturnal respiratory events in the majority of patients. Our objective is to determine the presence of HBP in pediatric patients with SDB and the impact of adenotonsillar surgery on its correction. Methodology: 286 children (4-18 years old) will be included consecutively referred for suspected SDB. Variables: a) Clinical history; b) Anthropometric variables: weight, height, body mass index, neck, hip and waist perimeter c) Chervin questionnaire d) polysomnography (PSG) for the SDB assessment and e) for the HBP evaluation, ambulatory blood pressure measurement (ABPM) will be performed during 24h. In control group (not SDB) and patients without treatment, the same tests will be repeated six months after the baseline visit. Patients with indication for medical treatment, ABPM and PSG will be performed 6 months after treatment initiation. In patients with surgery indication, ABPM will be performed just before the surgical treatment and ABPM and PSG six months after the intervention. In a subgroup of patients, it will be also assessed the presence of subclinical organic damage produced by HBP: blood markers (creatinine / glomerular filtration), urine (albuminuria / proteinuria), electrocardiogram and echocardiography (left ventricle hypertrophy).
详细描述
HYPOTHESIS Sleep Disorder Breathing (SDB) increase the appearance of High Blood Pressure (HBP) in pediatric patients. This HBP is reversible after treatment.
OBJECTIVES
Main goal:
- Demonstrate how the presence of SDB is associated with an increased risk of HBP in pediatric patients. Confirm that it is reversible with the treatment.
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Approval of the Ethics and Clinical Trials Committee
- •Informed consent signed by the parents and / or guardians
- •Children from 4 to 18 years old assessed consecutively due to SDB suspicion.
排除标准
- •Associated comorbidities: Cardiovascular (including cardiac malformation), cerebrovascular or severe unstable respiratory disease that makes it impossible to complete the studies
- •Genetic diseases
- •Children with chronic insomnia and / or depressive syndrome
- •Children with malformation syndromes (including craniofacial malformations), Down syndrome, and neuromuscular diseases
- •Previous otorhinolaryngologic surgery and / or CPAP treatment
- •Contraindication for the realization of the ABPM (arrhythmias, latex allergy or coagulation disease).
结局指标
主要结局
Mean systolic and diastolic blood pressure
时间窗: 6 months
Demonstrate how the presence of SDB is associated with an increased risk of HBP in pediatric patients. Confirm that it is reversible with the treatment
次要结局
- creatinine / glomerular filtration, albuminuria / proteinuria and left ventricle hypertrophy.(6 months)
- Apnea hypopnea index(6 months)
- blood pressure in clinic(6 months)
- Apnea hypopnea index(6 months)
- Percentage of change of mean blood pressure between day and night(6 months)
- blood pressure in clinic(6 months)
- creatinine / glomerular filtration, albuminuria / proteinuria and left ventricle hypertrophy.(6 months)
研究者
OlgaMediano
Principal Investigator
Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion