Cardiac Displacement From Third Trimester to Early Childhood
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Velocity of the Cardiac Walls cm/s Divided With Chamber Length in mm = Quota cm/s / mm
研究概览
简要总结
The aim is to increase awareness of the relationship between (IUGR) and cardiac function in the foetus, the development of cardiac function over time after delivery and what significance a possible early disturbed myocardial function have for the neonate and the child during the first years of life.
详细描述
This is a prospective case-control study in which fetuses from normal pregnancies will be compared with fetuses with IUGR. Parents will be asked to participate in the study in connection with the routine ultrasound examinations at the department of obstetrics to where they have been referred because of suspected IUGR. The control group will be randomly selected among pregnant women who come for routine ultrasound during pregnancy at gestational week 18-20.
Surveys will be performed in the third trimester and after delivery. During the ultrasound examinations standardized, moving sequences of the heart will be saved. Analyses will be performed off-line and analysed by vector velocity imaging software. With this technique, the investigator can quantify the chamber wall and myocardial movements. Speed (velocity), movement (displacement) and thickening/deformation (strain and strain rate) will be recorded in a structured and standardized manner.
When performing the analysis the heart's walls are outlined and the software extracts the movement in different directions.
Data will be obtained concerning the participating mothers previous illness, mothers' age, maternal smoking, BMI, any abnormalities during pregnancy, number of previous pregnancies. Other data that will be recorded are means of delivery and any abnormalities during previous pregnancies, such as hypertension, preeclampsia and pre-natal steroid treatment.
Additional data to be collected from the participating fetuses are flow profiles in the umbilical artery, ductus venosus and middle cerebral artery. Abdominal circumference and estimated weight will be registered.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion of research subjects: Growth restriction in routine pregnancy ultrasound, verified by specialist control. Gestational age based on Crown Rump Length measurements during the first trimester. Growth restriction defined by a deviation more than 22% from the normal curve at a given gestational age or growth rate deviates more than 10% compared to the previous measurement in relation to the expected weight.
- •Inclusion of controls: Control individuals recruited among mothers who come to routine pregnancy ultrasound control at gestational week
- •These are randomly selected and then asked to participate.
排除标准
- •Exclusion of both the cases with IUGR and the control cases are major malformations, twin pregnancy, signs of intrauterine infection during pregnancy, significant illness or significant medical treatment of the mother.
结局指标
主要结局
Velocity of the Cardiac Walls cm/s Divided With Chamber Length in mm = Quota cm/s / mm
时间窗: After delivery echocardiography were performed. This is one time point. Due to the known dramatic hemodynamic changes for all children right after birth we defined this time point to somewhere between 12 and 72 hours of age.
Echocardiography images of the heart's walls are outlined and the software extracts the movement in different directions. At each timepoint offline calculation were performed three times on each image and an averaged was calculated. The length of the heart from the level of the AV valve to the apex in left ventricle is used as a measurement for the size of the heart. As the velocity increases when the size of the heart increases a quota is used dividing the velocity by the length of the heart to be able to compare the velocity at different timepoints whe the child is growing. Quota=Left chamber velocity at septum stated in cm/s divided by ventricular length in mm.
次要结局
- Cardiac Marker Troponin T(At birth and at 9 years of age)
- Insulin-like Growth Factor Binding Protein (IGFBP)(At birth and at 9years of age)
- DNA Methylation and Gene Expression in Blood Monocytes and Lymphocytes(At birth and at 9 years of age)
- Left Chamber Longitudinal Displacement in the Septal Wall at the AV Valve Level Corrected for Ventricular Length Expressed as a Ratio.(After delivery echocardiography were performed. This is one time point. Due to the known dramatic hemodynamic changes for all children right after birth we defined this time point to somewhere between 12 and 72 hours of age.)
- Cardiac Marker N-terminal Prohormone of Brain Natriuretic Peptide (NT-ProBNP)(At birth and at 9 years of age)
- Insulin-like Growth Factor-1 (IGF-1)(At birth and at 9 years of age)
- Average Longitudinal 4 Segmental Strain in the Cardiac Wall. Shortening of the Myocardium in Systole.(At 3 months)
研究者
Olov Änghagen
Paediatrician, PhD student
University Hospital, Linkoeping