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Impact of Echocardiography on Management of Critically Ill Neonates

S

Sahar Abozkaly Mahmoud

Status

Enrolling

Conditions

Neonatology
Critical Illness
Echocardiography

Treatments

Device: Echocardiography

Study type

Observational

Funder types

Other

Identifiers

NCT06533787
Soh-Med-24-07-08MS

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

2 hours to 28 days old

Volunteers

Accepts Healthy Volunteers

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 .

Trial design

50 participants in 2 patient groups

Group 1
Description:
Hemodynamically unstable neonates
Treatment:
Device: Echocardiography
Group 2
Description:
Hemodynamically stable neonates
Treatment:
Device: Echocardiography

Trial contacts and locations

1

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Central trial contact

Sahar Abuzakaly Mahmoud, MBBS

Data sourced from clinicaltrials.gov

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