跳至主要内容
临床试验/NCT04720690
NCT04720690招募中不适用

Bioimpedence and Arterial Function Monitoring at Birth and in Infants: the BAMBI Study

Imperial College Healthcare NHS Trust2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Feasibility of arterial and cardiac function measurements: the proportion of babies from whom study measurements are successfully obtained.

研究概览

简要总结

Babies may be born appropriately grown for gestational age (AGA, >10th centile) or small for gestational age (SGA, <10th centile). Babies who are SGA and have evidence in utero of vascular compromise using antenatal doppler indices are classified as having fetal growth restriction (FGR). Babies with FGR are at increased risk of cardiovascular disease in adult life. Increased arterial stiffness and intima-media thickness are thought to mediate this risk in adults. It is not known how early in life these changes can be robustly detected. In addition, very little is known generally about how babies' hearts and arteries change in structure and function over the first year of life, whether affected by SGA or not. This study aims to understand if there are differences in cardiac and arterial structure and function between babies born AGA or SGA. Within the group of SGA babies, the study team will investigate whether FGR and maternal pre-eclampsia influence these measurements. The effects gestational age on these parameters will be studied within all groups: half of the babies recruited will be <32 weeks gestational age (GA), and half will be ≥32 weeks GA. Study participants will have further measurements at 3-6 months of life to assess if cardiac and arterial structure and function change in babies over the first year of life. The study team will use the Vicorder device to measure arterial stiffness, and assess the feasibility of using this device in neonates. The Vicorder will also be used to measure cardiac output. The feasibility and validity of this device for this purpose will be investigated (Vicorder is not validated for cardiac output measurement in infants). Vicorder cardiac output results will be compared to echocardiography and bioimpedence technology (using the NICaS monitor). The study team will use ultrasound for arterial structure measurements of the carotid artery and aorta.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy term infants (including those with SGA+/-FGR) in the postnatal ward
  • Term and Preterm infants (including those with SGA+/-FGR) admitted to the neonatal unit
  • Written informed parental consent

排除标准

  • Antenatal or postnatal diagnosis of complex/life-limiting congenital anomaly or genetic condition
  • Infants with no realistic chance of survival
  • Infants with fragile skin not permitting use of cuffs for research purposes
  • Babies whose parents have a limited understanding of English will be excluded in the event that communication via NHS translation services is not possible due to clinical demands on these services

结局指标

主要结局

Feasibility of arterial and cardiac function measurements: the proportion of babies from whom study measurements are successfully obtained.

时间窗: 3 years

Feasibility of arterial and cardiac function measurements assessed through establishing from what proportion of babies the team is able to successfully obtain these measurements.

次要结局

  • Non-invasive measurement of arterial stiffness: brachial-femoral pulse wave velocity(3 years)
  • Arterial structure measurements(3 years)
  • Cardiac output measurements: comparison of neonatal and infant birth weight and gestational age cohorts(3 years)
  • Cardiac output measurements: comparison of devices(3 years)
  • Non-invasive measurement of arterial stiffness: augmentation index(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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