Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure
2021年11月2日 更新者：Marwa Mohamed Farag
The aim of the present prospective study was to evaluate dynamic changes in both pulmonary artery pressure and ductus arteriosus during the first 72 hours after birth.
研究概览
地位
完全的
条件
详细说明
Healthy newborn infants born in Alexandria University Children's Hospital were studied.
Dynamic changes during the first 72 hours after birth were evaluated.
研究类型
观察性的
注册 (实际的)
110
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Alexandria、埃及、21131
- Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
1秒 至 6小时 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Healthy newborn infants born in Alexandria University Children's Hospital were studied.
Dynamic changes in both pulmonary artery pressure and ductus arteriosus during the first 72 hours after birth were evaluated.
描述
Inclusion Criteria:
- Gestational age: 37-42 weeks.
- Birthweight: 2500-4000 g.
Exclusion Criteria:
- Neonates more than 6 hours of age at time of enrollment.
- Perinatal asphyxia or hypoxia (1 min Apgar scoring<7 points)
- Cardiac structural abnormalities detected by echocardiography except patent foramen ovale and patent ductus arteriosus
- Other clinically detected congenital malformations such as cleft lip and palate, omphalocele, meningocele, etc.
- Maternal history of gestational hypertension, gestational diabetes, hyperthyroidism, hypothyroidism, and autoimmune disease
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pulmonary artery pressure (PAP) assessment - Tricuspid valve regurgitation peak velocity
大体时间：up to 72 hours
|
This is measured in apical 4 chamber view, with continuous wave Doppler using modified Bernoulli equation. Systolic pulmonary artery pressure is equivalent to right ventricular systolic pressure in absence of outflow obstruction. Systolic Pulmonary Artery Pressure (SPAP) = Right Ventricular Systolic Pressure = 4x TR2 + Right Atrial Pressure (RAP) (RAP= 3-5 mmHg) |
up to 72 hours
|
|
Pulmonary artery pressure (PAP) assessment - Pulmonary regurgitation peak velocity
大体时间：up to 72 hours
|
This is measured in short axis parasternal view with continuous wave Doppler using this equation: Mean Pulmonary Artery Pressure MPAP= 4xPR2 + Right Ventricular Diastolic Pressure (RVdP=2-5 mmHg)
|
up to 72 hours
|
|
Pulmonary artery pressure (PAP) assessment - Transductal right-to-left flow peak velocity
大体时间：up to 72 hours
|
This is measured in high short axis ductal view with continuous wave Doppler
|
up to 72 hours
|
|
Pulmonary artery pressure (PAP) assessment - Interventricular septum configuration
大体时间：up to 72 hours
|
This is measured in short axis parasternal view above level of papillary muscles, left ventricle is normally O shaped, D or crescent shape indicated bowing of septum due to RV dysfunction.
|
up to 72 hours
|
|
Pulmonary artery pressure (PAP) assessment - Left ventricle systolic eccentricity index (LV-sEI)
大体时间：up to 72 hours
|
This is measured in short axis parasternal view by measuring LV dimensions the parallel versus the perpendicular dimension.
The normal ratio is 1.
|
up to 72 hours
|
|
Right ventricular performance - Tricuspid annular plane systolic excursion(TAPSE)
大体时间：up to 72 hours
|
This is measured using Mmode in apical 4 chamber view over lateral annulus of tricuspid valve
|
up to 72 hours
|
|
Right ventricular performance - Myocardial Performance Index (MPI)
大体时间：up to 72 hours
|
This is measured by using pulsed wave doppler to measure isovolumetric ejection time + isovolumetric relaxation time/ right ventricular ejection time.
|
up to 72 hours
|
|
Right ventricular performance - E/A ratio
大体时间：up to 72 hours
|
This is measured in apical 4 chamber view by pulsed wave Doppler on mitral valve.
The cut off value: 0.8- 2.
|
up to 72 hours
|
|
Left ventricular performance - Ejection fraction
大体时间：up to 72 hours
|
This is measured using M-Mode in long axis parasternal view with a normal range of 55-75%
|
up to 72 hours
|
|
Left ventricular performance - E/A ratio
大体时间：up to 72 hours
|
This is measured in apical 4 chamber view by pulsed wave Doppler on mitral valve.
The cut off value: 0.8- 2
|
up to 72 hours
|
|
Shunts evaluation - Patent Ductus arteriosus
大体时间：up to 72 hours
|
Size will be evaluated in short axis parasternal view
|
up to 72 hours
|
|
Shunts evaluation - Patent Ductus arteriosus
大体时间：up to 72 hours
|
Direction will be evaluated in short axis parasternal view using color Doppler
|
up to 72 hours
|
|
Shunts evaluation - Patent Foramen Ovale
大体时间：up to 72 hours
|
Size will be evaluated in be viewed in subcostal view
|
up to 72 hours
|
|
Shunts evaluation - Patent Foramen Ovale
大体时间：up to 72 hours
|
Direction will be evaluated in subcostal view using color Doppler
|
up to 72 hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Aly M Abdel-Mohsen, PhD、Faculty of Medicine, Alexandria University, Egypt
- 首席研究员：Rana EO Kandil, MBBCh、Faculty of Medicine, Alexandria University, Egypt
- 研究主任：Mohamed A Khalifa, MBBCh、Faculty of Medicine, Alexandria University, Egypt
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年8月1日
初级完成 (实际的)
2021年8月10日
研究完成 (实际的)
2021年8月15日
研究注册日期
首次提交
2021年9月10日
首先提交符合 QC 标准的
2021年9月10日
首次发布 (实际的)
2021年9月20日
研究记录更新
最后更新发布 (实际的)
2021年11月4日
上次提交的符合 QC 标准的更新
2021年11月2日
最后验证
2021年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.