Impact of Echocardiography on Management of Critically Ill Neonates

NCT06533787 | Recruiting

• 1 other identifier: Soh-Med-24-07-08MS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Echocardiography; Neonatology

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (2)

Group 1

Hemodynamically unstable neonates

Device: Echocardiography

Group 2

Hemodynamically stable neonates

Device: Echocardiography

Interventions

Echocardiography DEVICE

Functional echocardiography assessment

Group 1; Group 2

Eligibility Criteria

• Age: 2 Hours - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Failure to obtain informed consent .
• Presence of congenital heart disease apart from PDA , PFO \& small ASD .

Sponsors & Collaborators

• Sahar Abozkaly Mahmoud: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (7)

• 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.

  PMID: 17236886 BACKGROUND

• 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.

  PMID: 20877406 BACKGROUND

• 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.

  PMID: 9496187 BACKGROUND

• 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.

  PMID: 15711976 BACKGROUND

• 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.

  PMID: 20171815 BACKGROUND

• 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.

  PMID: 17951547 BACKGROUND

• 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.

  PMID: 18633423 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Sahar Abuzakaly Mahmoud, MBBS

CONTACT

01145168107; sahar.abozakaly@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident doctor of pediatrics at Sohag university hospital

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

EG (1)