Impact of Echocardiography on Management of Critically Ill Neonates

Recruiting

• Conditions: Critical Illness; Echocardiography; Neonatology
• Interventions: Device: Echocardiography

• Registration Number: NCT06533787
• Lead Sponsor: Sahar Abozkaly Mahmoud

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.

Study Timeline

• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Study Start: 2024-08-01
• Study First Posted: 2024-08-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Echocardiography	Hemodynamically stable neonates
Group 1	Echocardiography	Hemodynamically unstable neonates

Primary Outcome Measures

Name	Time	Method
Assessment of ductus arteriosus ( diameter, shunt directionality ) by 2D and color doppler echocardiography	Repeat echocardiographic assessment 5 days after the first echo assessment
Assessment of RV function	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	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	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)	Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
Functional echocardiography fraction shortening by M mode echocardiography	Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
Assessment of RV cardiac index	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	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

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt