Evaluation of the Effect of Placental Transfusion on Hemodynamics in Premature Newborns
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Evaluation of superior vena cava flow (SVC) flow by echocardiography
研究概览
简要总结
The objective of this study is to perform ultrasound Doppler measurements to evaluate the hemodynamic changes associated with different methods of placental transfusion (Intact umbilical cord milking, cut- umbilical cord milking and delayed cord clamping) in premature neonates over the first days of life.
详细描述
This study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital. Evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (NICU) at Alexandria University Children's Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature neonates ≤ 32 weeks gestational age regardless birth weight who will be admitted to neonatal intensive care unit in the first day of life.
排除标准
- •Preterm babies >32 weeks
- •Major congenital anomalies (complex cyanotic heart disease, major central nervous system anomalies).
- •Evidence of head trauma causing major intracranial hemorrhage.
- •Monochorionic multiples.
- •Concern for abruptions, placenta previa or retroplacental hematoma.
- •Cord accident, or avulsion at the time of delivery.
- •Refusal to perform the intervention by the obstetrician
结局指标
主要结局
Evaluation of superior vena cava flow (SVC) flow by echocardiography
时间窗: up to 3 days of life
Infants are placed in supine position on a flat surface and heart is imaged from a low subcostal view. SVC flow is identified by angling the beam anteriorly until the flow into the right atrium from SVC is seen using color Doppler. SVC diameter will be seen from a high parasternal long axis (PLAX) view. The transducer will be placed as close to the midline as possible to acquire directly anteroposterior views of SVC. Maximum and minimum internal diameters will be measured off-line from a frozen 2D image showing the vessel walls at the point where SVC starts to open into the right atrium. Due to the variation in vessel diameter through the cardiac cycle, mean of the maximum and minimum diameter is used for flow calculation. The velocity time integral (VTI) will be calculated from the Doppler velocity tracings and averaged over 5 consecutive cardiac cycles. SVC flow will be calculated using the Kluckow and Evans method = (VTI × 3.14 × (mean SVC diameter2/4) × heart rate) / body weight.
Measurement of fractional shortening (FS) by echocardiography
时间窗: up to 3 days of life
The FS is obtained from M-mode tracings or 2D imaging in the PLAX view at the tips of the mitral valve leaflets or in the parasternal short-axis (PSAX) view at the level of the papillary muscles. The left ventricular M-mode tracing is obtained from the PLAX or PSAX view. The cursor in M-mode should be placed perpendicular to the interventricular septum and posterior wall at the level of the posterior mitral valve leaflet. Left ventricular end-diastolic dimension (LVEDD) and left ventricular end-systolic dimension (LVESD) will be measured, and the FS is calculated using the following equation: FS (%) = (LVEDD - LVESD / LVEDD) × 100
Evaluation of ejection fraction (EF) by echocardiography
时间窗: up to 3 days of life
Left ventricular end-diastolic dimension (LVEDD) and left ventricular end-systolic dimension (LVESD) will be measured to calculate the ejection fraction. The EF is calculated using the following equation: EF (%) = (LVEDV - LVESV/ LVEDV)× 100
Evaluation of the pulse wave by echocardiography
时间窗: up to 3 days of life
The pulse wave (PW) Doppler across mitral inflow is composed of two waves: an E wave representing early passive ventricular filling (preload dependent) and an A wave representing late diastolic active filling as a result of atrial contraction.
Evaluation of left ventricular diastolic function by echocardiography
时间窗: up to 3 days of life
The mitral E/A ratio and velocity will be done for assessment of left ventricular diastolic function.
Evaluation of cardiac output (CO)
时间窗: up to 3 days of life
The echocardiographic assessment of the CO can be obtained by measuring cross-sectional area (CSA) of the left or RV outflow tract at the level of aortic or pulmonary annulus and by measuring the velocity time integral (VTI) at the level of aortic or pulmonary valve by pulsed wave Doppler, respectively. The CO is calculated by using the following equation: Cardiac Output (CO)=SV×HR= VTI× CSA× Heart Rate
Evaluation of patent ductus arteriosus (PDA)
时间窗: up to 3 days of life
The left-sided parasternal "ductal" view is the window to obtain a clear 2D image of the ductus arteriosus. The ultrasound probe is placed in a true sagittal plane to the left of the sternum with the marker pointing toward the head to obtain the ductal view. The PDA is visualized as a structure leaving the left side of the junction of the main pulmonary artery and the left pulmonary artery (LPA) toward the descending aorta. Color Doppler may be used to visualize the direction of transductal blood flow. The transdustal diameter will be measured in this view. Velocity and direction of the shunt during the cardiac cycle can be obtained by applying continuous wave.
次要结局
未报告次要终点
研究者
Marwa Mohamed Farag
Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine
Alexandria University