Clinical trial NCT06533787: Impact of Echocardiography on Management of Critically Ill Neonates
Official title: Impact of Echocardiography on Management of Critically Ill Neonates
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Echocardiography
Neonatology
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates ( age 0 to 28 days) admitted to the NICU of Sohag University Hospital during the period of the study

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Functional echocardiography ( ejection fraction using M mode echocardiography)
timeFrame: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
measure: Functional echocardiography fraction shortening by M mode echocardiography
timeFrame: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
measure: Assessment of ductus arteriosus ( diameter, shunt directionality ) by 2D and color doppler echocardiography
timeFrame: Repeat echocardiographic assessment 5 days after the first echo assessment
measure: Assessment of pulmonary hypertension
timeFrame: Repeat echocardiographic assessment on a daily basis ( 24 hours interval) following proposed treatment of pulmonary hypertension
measure: Assessment of LV cardiac index
timeFrame: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
measure: Assessment of RV cardiac index
timeFrame: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
measure: Assessment of SVC flow
timeFrame: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
measure: Assessment of RV function
timeFrame: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
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citation: Egan JR, Festa M, Cole AD, Nunn GR, Gillis J, Winlaw DS. Clinical assessment of cardiac performance in infants and children following cardiac surgery. Intensive Care Med. 2005 Apr;31(4):568-73. doi: 10.1007/s00134-005-2569-5. Epub 2005 Feb 15.
citation: de Boode WP. Clinical monitoring of systemic hemodynamics in critically ill newborns. Early Hum Dev. 2010 Mar;86(3):137-41. doi: 10.1016/j.earlhumdev.2010.01.031. Epub 2010 Feb 20.
citation: McNamara PJ, Sehgal A. Towards rational management of the patent ductus arteriosus: the need for disease staging. Arch Dis Child Fetal Neonatal Ed. 2007 Nov;92(6):F424-7. doi: 10.1136/adc.2007.118117.
citation: Sehgal A, McNamara PJ. Does point-of-care functional echocardiography enhance cardiovascular care in the NICU? J Perinatol. 2008 Nov;28(11):729-35. doi: 10.1038/jp.2008.100. Epub 2008 Jul 17.