Myocardial Deformation Before and After Birth, and Under Altered Preload, Afterload and Heart Rate in New-borns
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Changes in myocardial function
研究概览
简要总结
Knowledge on the changes in myocardial function in the last weeks before birth and during the first year of life is limited. Through fetal and post-natal echocardiography we intend to describe these changes using myocardial tissue recognition techniques (Speckle tracking echocardiography and Tissue Doppler echocardiography) in healthy neonates, born to term of healthy women after uncomplicated pregnancies. We will compare the findings in this cohort to a cohort of neonates born to term of women with severe pre-pregnancy obesity.
Sick neonates in intensive care units with various cardiac and non-cardiac conditions are often exposed to treatment that may affect both their cardiac function and important echo-variables per se. Using echocardiography, we will examine these changes in neonates treated with blood transfusion, catecholamines and in those treated with Ibuprofen due to a haemodynamic significant arterial duct.
详细描述
Before, during and after birth major changes take place in the cardiovascular system. The last weeks prior to birth there is an oxidative stress and after birth, there is normally a large step up in blood oxygen tension when the lungs take over oxidation of the blood. Simultaneously there are changes in the vascular resistance in both the pulmonary- and systemic part of the circulation and ductus venous, the arterial duct, and foramen ovale close. Combined these will significantly alter the physical conditions under which the myocardium is supposed to work.
This project will have five arms, all based on measurements of myocardial function and coronary perfusion by speckle tracking echocardiography (STE) in the last trimester of the pregnancy and in newborns with different gestational age and in sick newborns where myocardial function is affected by medical treatment or is an important part of the clinical situation.
- Obtaining normal values for strain during the last trimester of the pregnancy and the first days after birth in child born to term.
Hypothesis: After birth, there will be higher STE values in the left ventricle than before birth. This will increase further the first days post-partum in parallel with an altered hemodynamic situation and oxygen demand of the infant. The STE changes will take place at the same time, as there is an increased Doppler velocity in the aorta, the pulmonary artery and the coronary arteries
Mothers (N= 150) will be recruited when they are coming to a routine fetal ultrasound scan. It will be made an echo-examination once per week from week 37 until birth. After birth the degree of placental transfusion (late cord clamping or not) will be noticed. Ventricular size, Doppler velocities in the ascending aorta and pulmonary artery, STE and coronary flow during the first three days of life and one year of age will be assessed 2. Evaluate the effect of maternal obesity on cardiac function in newborns up to one year of age.
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 3 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal pregnancies
- •Newborns in need of blood transfusion
- •Newborns in need of medical closure of the arterial duct
- •Maternal obesity
排除标准
- •Abnormal pregnancies except maternal obesity
- •Congenital heart defects
- •Other malformation syndromes
研究组 & 干预措施
New-borns in need of blood transfusion
Neonates mainly receive blood due to blood loss, often because of repeated blood sampling
干预措施: Blood transfusion, Ibuprofen, or epinephrine, norepinephrine or dopamine (Drug)
New-borns in need for closure of the arterial duct
Neonates mainly receive medication (Ibuprofen) because of symptoms like apnea, due to their patent arterial duct.
干预措施: Blood transfusion, Ibuprofen, or epinephrine, norepinephrine or dopamine (Drug)
结局指标
主要结局
Changes in myocardial function
时间窗: Maximum 1 year and 5 weeks
Per cent change in longitudinal global strain
次要结局
未报告次要终点
研究者
Gottfried Greve
Consultant/ Professor
Haukeland University Hospital