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Recruiting Observational

Impact of Echocardiography on Management of Critically Ill Neonates

NCT06533787 · tracked via the Priya Life Science Egypt tracker
Sponsor
Sahar Abozkaly Mahmoud
Phase
Observational
Started
2024-08-01
Last updated
2025-06-03

Condition(s) studied

Critical IllnessEchocardiographyNeonatology

Investigational drug(s) / intervention(s)

Echocardiography

Echocardiography: Functional echocardiography assessment

Study 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.

Eligibility

Sex
ALL
Min age
2 Hours
Max age
28 Days
Healthy volunteers
Accepted
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 outcome measure(s)

  • 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 — Repeat echocardiographic assessment on a daily basis ( 24 hours interval) following proposed treatment of pulmonary hypertension
    Using peak tricuspid regurgitation velocity by colour doppler
  • Assessment of LV cardiac index — 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
  • Assessment of RV cardiac index — 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
  • Assessment of SVC flow — 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
  • Assessment of RV function — 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

Trial sites (1)

FacilityCityRegionStatus
Sohag University Hospital Sohag Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06533787 on ClinicalTrials.gov ↗ ← All trials in Egypt