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NCT Number: NCT06533787

Impact of Echocardiography on Management of Critically Ill Neonates

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.

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Key information

Conditions

Critical Illness Disease Attributes Echocardiography Neonatology Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 hour–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University Hospital

Sohag, Egypt

Location status: Recruiting

Location contact

Sahar Abuzakaly Mahmoud, MBBS

CONTACT

About this study

-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:

  • 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].
  • 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].
  • 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].
  • Neonates with normal or high LVO and hemodynamically significant PDA: PDA will be treated either medically or surgically [11].
  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Echocardiography

Device

Functional echocardiography assessment

Primary outcomes

  1. Functional echocardiography ( ejection fraction using M mode echocardiography)

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

  2. Functional echocardiography fraction shortening by M mode echocardiography

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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sahar Abuzakaly Mahmoud, MBBS

CONTACT

[email protected]

01145168107

Sponsors and collaborators

Lead sponsor

Sahar Abozkaly Mahmoud

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2024
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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