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Impact of Echocardiography on Management of Critically Ill Neonates

Impact of Echocardiography on Management of Critically Ill Neonates

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06533787
Enrollment
50
Registered
2024-08-01
Start date
2024-08-01
Completion date
2025-08-31
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Echocardiography, Neonatology

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.

Interventions

DEVICEEchocardiography

Functional echocardiography assessment

Sponsors

Sahar Abozkaly Mahmoud
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Hours to 28 Days
Healthy volunteers
Yes

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 .

Design outcomes

Primary

MeasureTime frameDescription
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 echocardiographyRepeat echocardiographic assessment on a daily basis ( 24 hours interval)
Assessment of ductus arteriosus ( diameter, shunt directionality ) by 2D and color doppler echocardiographyRepeat echocardiographic assessment 5 days after the first echo assessment
Assessment of pulmonary hypertensionRepeat echocardiographic assessment on a daily basis ( 24 hours interval) following proposed treatment of pulmonary hypertensionUsing peak tricuspid regurgitation velocity by colour doppler
Assessment of LV cardiac indexRepeat 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
Assessment of RV cardiac indexRepeat 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 flowRepeat 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
Assessment of RV functionRepeat 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

Countries

Egypt

Contacts

Primary ContactSahar Abuzakaly Mahmoud, MBBS
sahar.abozakaly@med.sohag.edu.eg01145168107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026