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Clinical Trials/NCT06533787
NCT06533787
Recruiting
N/A

Impact of Echocardiography on Management of Critically Ill Neonates

Sahar Abozkaly Mahmoud1 site in 1 country50 target enrollmentAugust 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Sahar Abozkaly Mahmoud
Enrollment
50
Locations
1
Primary Endpoint
Assessment of ductus arteriosus ( diameter, shunt directionality ) by 2D and color doppler echocardiography
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

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.

Detailed Description

-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.

Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
August 2025
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sahar Abozkaly Mahmoud
Responsible Party
Sponsor Investigator
Principal Investigator

Sahar Abozkaly Mahmoud

Resident doctor of pediatrics at Sohag university hospital

Sohag University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Repeat echocardiographic assessment 5 days after the first echo assessment

Assessment of RV function

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)

Functional echocardiography fraction shortening by M mode echocardiography

Time Frame: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)

Assessment of RV cardiac index

Time Frame: 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

Time Frame: 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

Study Sites (1)

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