Critical IllnessNCT06533787
Impact of Echocardiography on Management of Critically Ill Neonates
An observational study of Critical Illness and Echocardiography, run by Sahar Abozkaly Mahmoud at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 hours to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, Echocardiography, Neonatology
- What is being tested?
- Echocardiography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 hours to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates ( age 0 to 28 days) admitted to the NICU of Sohag University Hospital during the period of the study
Who may be able to join
- 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.
Who cannot join
- Failure to obtain informed consent .
- Presence of congenital heart disease apart from PDA , PFO \& small ASD .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Sahar Abuzakaly Mahmoud, MBBS
About this study
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.
Read the 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:
- 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.
- Conditions
- Critical Illness, Echocardiography, Neonatology
- Being tested
- Echocardiography
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDevice
Functional echocardiography assessment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Hemodynamically unstable neonates Receives: Device: Echocardiography | |
| Group 2 | Hemodynamically stable neonates Receives: Device: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional echocardiography ( ejection fraction using M mode echocardiography)
Measured: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
Functional echocardiography fraction shortening by M mode echocardiography
Measured: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
Assessment of ductus arteriosus ( diameter, shunt directionality ) by 2D and color doppler echocardiography
Measured: Repeat echocardiographic assessment 5 days after the first echo assessment
Assessment of pulmonary hypertension
Using peak tricuspid regurgitation velocity by colour doppler
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Aug 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahar Abozkaly Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sahar Abozkaly Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533787
- Sponsor's protocol ID
- Soh-Med-24-07-08MS
- Status last verified
- May 2025
- First submitted
- 30 Jul 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17236886Soleymani 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.
PubMed 20877406Tibby 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.
PubMed 9496187Egan 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.
PubMed 15711976de 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.
PubMed 20171815McNamara 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.
PubMed 17951547Sehgal 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.
PubMed 18633423
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Echocardiography on Management of Critically Ill Neonates
- ClinicalTrials.gov ID
- NCT06533787
- Acronym / sponsor ID
- Soh-Med-24-07-08MS
- Conditions
- Critical Illness, Echocardiography, Neonatology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sahar Abozkaly MahmoudUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: EchocardiographyHemodynamically unstable neonates |
| Group 2 | – | Device: EchocardiographyHemodynamically stable neonates |
Who may qualify
- Ages
- 2 hours to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates ( age 0 to 28 days) admitted to the NICU of Sohag University Hospital during the period of the study
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Failure to obtain informed consent .
- Presence of congenital heart disease apart from PDA , PFO \& small ASD .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyFunctional echocardiography assessment | Device | Group 1, Group 2 |
Primary outcome
Functional echocardiography ( ejection fraction using M mode echocardiography)
Time frame: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
Functional echocardiography fraction shortening by M mode echocardiography
Time frame: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 17236886Kluckow 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.
- Background: PubMed 20877406Soleymani 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.
- Background: PubMed 9496187Tibby 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.
- Background: PubMed 15711976Egan 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.
- Background: PubMed 20171815de 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.
- Background: PubMed 17951547McNamara 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.
- Background: PubMed 18633423Sehgal 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Echocardiography, run by Sahar Abozkaly Mahmoud at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sahar Abuzakaly Mahmoud, MBBS (01145168107, sahar.abozakaly@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional echocardiography ( ejection fraction using M mode echocardiography) (time frame: Repeat echocardiographic assessment on a daily basis ( 24 hours interval)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06533787, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.