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临床试验/NCT06533787
NCT06533787招募中不适用

Impact of Echocardiography on Management of Critically Ill Neonates

Sahar Abozkaly Mahmoud1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Assessment of ductus arteriosus ( diameter, shunt directionality ) by 2D and color doppler echocardiography

研究概览

简要总结

The goal of the study was to estimate the outcome (mortality and morbidity) among hemodynamically unstable neonates, as well as the time to return to hemodynamic stability following the use of ECHO in the management of hemodynamically unstable neonates.

详细描述

-All patients will be subjected to : Full clinical examination for manifestation or signs of hemodynamic instability and daily thereafter until discharge.

An echocardiographic assessment using Vivid T8 Pro ( GE MEDICAL SYSTEMS ( CHINA ) CO, LTD.) is done if manifestations of hemodynamic instability or shock appeared.

The imaging planes were identified by transducer location (subxiphoid, apical, parasternal, suprasternal notch, and right parasternal). The segmental approach was used to describe all of the major cardiovascular structures in sequence.

Suggested plan of management will be as the following:

  1. Neonates with low LVO and impaired left ventricular contractility: dobutamine at a dose of 5-20 μg/kg/min was given, and if no improvement, volume expansion as a single intravenous infusion of 10-20 ml/kg of the crystalloid solution was given. If still no improvement, hydrocortisone at a dose of 1 mg/kg every 4 h was added. If improvement was not achieved, epinephrine was added at a dose of 0.05-2.6 μg/kg/min [11].
  2. Neonates with LVO and hypovolemia (under-filled left ventricle): volume expansion as a single intravenous infusion of 10-20 ml/kg of the crystalloid solution will be given. If still no improvement, it was repeated [11].
  3. Neonates with normal or high LVO without PDA: dopamine at a dose of 5-20 μg/kg/min is given. If no improvement, hydrocortisone at a dose of 1 mg/kg every 4 h is added. If improvement was not achieved, epinephrine is added at a dose of 0.05-2.6 μg/kg/min [11].
  4. Neonates with normal or high LVO and hemodynamically significant PDA: PDA will be treated either medically or surgically [11].
  5. During the current study period, all previously mentioned hemodynamically unstable neonate values were compared to values collected from the controlled group (200 hemodynamically stable neonates).
  6. Neonates will be monitored regularly and subjected to repeated echocardiographic and clinical examinations to detect clinical and laboratory findings suggestive of hemodynamic instability or shock.

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
2 Hours 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • All neonates ( age 0 to 28 days) admitted to the NICU of Sohag University Hospital during the period of the study in whom manifestations of hemodynamic instability or critical illness were elected regardless of gestational age, weight, gender, or type of disease.

排除标准

  • Failure to obtain informed consent .
  • Presence of congenital heart disease apart from PDA , PFO & small ASD .

结局指标

主要结局

Assessment of ductus arteriosus ( diameter, shunt directionality ) by 2D and color doppler echocardiography

时间窗: Repeat echocardiographic assessment 5 days after the first echo assessment

Assessment of RV function

时间窗: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)

Measurement of Tricuspid annular plane systolic excursion (TAPSE) using M mode echocardiography in apical four chamber view

Assessment of pulmonary hypertension

时间窗: Repeat echocardiographic assessment on a daily basis ( 24 hours interval) following proposed treatment of pulmonary hypertension

Using peak tricuspid regurgitation velocity by colour doppler

Assessment of LV cardiac index

时间窗: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)

Assessment of LV outflow tract diameter by 2D/M mode echocardiography in parasternal long axis view and assessment of Velocity-time integral of PW in LV outflow tract by PW doppler in apical five-chamber view

Functional echocardiography ( ejection fraction using M mode echocardiography)

时间窗: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)

Functional echocardiography fraction shortening by M mode echocardiography

时间窗: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)

Assessment of RV cardiac index

时间窗: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)

Assessment of RV outflow tract diameter by 2D echocardiography and Velocity-time integral of PW in RV outflow tract

Assessment of SVC flow

时间窗: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)

Assessment of SVC diameter (mean of systolic and diastolic diameter) by M mode echocardiography in high parasternal view

次要结局

未报告次要终点

研究者

发起方
Sahar Abozkaly Mahmoud
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sahar Abozkaly Mahmoud

Resident doctor of pediatrics at Sohag university hospital

Sohag University

研究点 (1)

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