NCT06533787

Impact of Echocardiography on Management of Critically Ill Neonates

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Sahar Abozkaly Mahmoud · Academic / Other
• Sex: All
• Age: 2 Hours – 28 Days
• Healthy volunteers: Accepted

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.

Conditions

• Critical Illness
• Echocardiography
• Neonatology

Interventions

Type	Name	Description
DEVICE	Echocardiography	Functional echocardiography assessment

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-08-01
• Last updated: 2025-06-03

Locations

1 site across 1 country: Egypt