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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Echocardiography; Neonatology
• Intervention / Treatment: Device: Echocardiography

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Sahar Abuzakaly Mahmoud, MBBS; Phone Number: 01145168107; Email: sahar.abozakaly@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University Hospital
    • Contact: Sahar Abuzakaly Mahmoud, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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

Description

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 .

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Hemodynamically unstable neonates	Device: Echocardiography; Functional echocardiography assessment
Group 2; Hemodynamically stable neonates	Device: Echocardiography; Functional echocardiography assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 echocardiography		Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
Assessment of ductus arteriosus ( diameter, shunt directionality ) by 2D and color doppler echocardiography		Repeat echocardiographic assessment 5 days after the first echo assessment
Assessment of pulmonary hypertension	Using peak tricuspid regurgitation velocity by colour doppler	Repeat echocardiographic assessment on a daily basis ( 24 hours interval) following proposed treatment of pulmonary hypertension
Assessment of LV cardiac index	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	Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
Assessment of RV cardiac index	Assessment of RV outflow tract diameter by 2D echocardiography and Velocity-time integral of PW in RV outflow tract	Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
Assessment of SVC flow	Assessment of SVC diameter (mean of systolic and diastolic diameter) by M mode echocardiography in high parasternal view	Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
Assessment of RV function	Measurement of Tricuspid annular plane systolic excursion (TAPSE) using M mode echocardiography in apical four chamber view	Repeat echocardiographic assessment on a daily basis ( 24 hours interval)

Collaborators and Investigators

• Sponsor: Sahar Abozkaly Mahmoud

Publications and helpful links

General Publications

• Tibby SM, Hatherill M, Marsh MJ, Murdoch IA. Clinicians' abilities to estimate cardiac index in ventilated children and infants. Arch Dis Child. 1997 Dec;77(6):516-8. doi: 10.1136/adc.77.6.516.
• 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.
• Kluckow M, Seri I, Evans N. Functional echocardiography: an emerging clinical tool for the neonatologist. J Pediatr. 2007 Feb;150(2):125-30. doi: 10.1016/j.jpeds.2006.10.056. No abstract available.
• Soleymani S, Borzage M, Seri I. Hemodynamic monitoring in neonates: advances and challenges. J Perinatol. 2010 Oct;30 Suppl:S38-45. doi: 10.1038/jp.2010.101.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 31, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: Soh-Med-24-07-08MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No