Study of the Effect of Hydrocortisone Administered for the Prevention of Pulmonary Bronchodysplasia (PREMILOC Trial) on the Determinants of Systemic Blood Pressure in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Velocity of the carotid-femoral pulse wave in m/s (VOP)
研究概览
简要总结
The risk of Arterial Hypertension (HTA) is increased in very premature infants and hydrocortisone administered in the neonatal period could modify this risk.
The main objective is to assess whether the administration of hydrocortisone in the perinatal period in children born prematurely is associated with an increase in Pulse Wave Velocity (PWV) by comparing the future of children included in the PREMILOC trial (hydrocortisone versus placebo) at the age of 7-13 years. The primary endpoint will be the carotid-femoral pulse wave velocity in m/s.
详细描述
Descriptive cross-sectional study of the subjects included in the double-blind, monocentric randomized controlled trial (children included and followed up at the Robert Debré hospital in the PREMILOC trial): follow-up of these children approximately 10 years later on vascular parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The treatment having been received previously in the PREMILOC trial, no one knows which treatment the patients received.
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child included in the PREMILOC trial on the Robert Debré site
- •Age from 7 to 13 years old (eve of 14 years old)
- •Consent of the holders of parental authority and agreement of the child
排除标准
- •Absence of affiliation to a social security scheme
- •Patient under state medical aid
研究组 & 干预措施
Hydrocortisone
During the PREMILOC trial, patients received hydrocortisone (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).
干预措施: blood pressure measurement (Diagnostic Test)
Placebo
During the PREMILOC trial, patients received placebo (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).
干预措施: blood pressure measurement (Diagnostic Test)
结局指标
主要结局
Velocity of the carotid-femoral pulse wave in m/s (VOP)
时间窗: Inclusion
Velocity of the carotid-femoral pulse wave in m/s measured by the SphygmoCor device.
次要结局
- Other factors associated with the risk of early hypertension: Fetal growth restriction(Data retrieved on inclusion)
- Index increase of VOP(Inclusion)
- Cardio-Radial Pulse Wave Velocity(Inclusion)
- Other factors associated with the risk of early hypertension: presence of overweight(Data retrieved on inclusion)
- Other factors associated with the risk of early hypertension: daily physical activity(Data retrieved on inclusion)
- Other factors associated with the risk of early hypertension: quality of life(Data retrieved on inclusion)
- Other factors associated with the risk of early hypertension: etnicity(Data retrieved on inclusion)
- Sensitivity of the baroreflex(Inclusion)
- Parameters from ambulatory blood pressure measurement (ABPM)(During 24 hours)
- Low Frequence/High Frequence ratio of the sympatho-vagal balance(Inclusion)
- High Frequence bare of the sympatho-vagal balance(Inclusion)
- Low frequence bare of the sympatho-vagal balance(Inclusion)