Patent Ductus Arteriosus in Preterm InfantsNCT06606015
Noninvasive Hemodynamics Assessment of Preterms With Successful Medical Closure of PDA
An observational study of Patent Ductus Arteriosus in Preterm Infants, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of our study was to use Electrical Cardiometry EC to monitor hemodynamic alternations during pharmacological closure of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm neonates Read more about this study
- Who is it for?
- Ages 24 hours to 7 days
- Conditions the study is for
- Patent Ductus Arteriosus in Preterm Infants
- What is being tested?
- I.V Paracetamol., Echocardiography. and Electrical Cardiometry
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 24 hours to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: This study included 43 preterm neonates with hemodynamically significant PDA who received IV paracetamol as PDA medical closure. They were subdivided into 2 main groups responders and non responders to the PDA closure treatment.
Who may be able to join
- All preterm newborns who were admitted throughout the duration of the research.
Who cannot join
- Newborn with congenital heart diseases.
- Newborn with acquired heart diseases (viral myocarditis)
- Newborn with dysrhythmias
- Newborn with symptomatic cardiac dysfunction secondary to extra cardiac diseases
- Newborn with significant pulmonary hypertension or systemic hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive Hemodynamics Assessment of Preterm Newborns With Successful Medical Closure of Patent Ductus Arteriosus
The aim of our study was to use Electrical Cardiometry EC to monitor hemodynamic alternations during pharmacological closure of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm neonates
Read the detailed description
PDA in the first three days of life is a normal physiologic remnant in healthy term neonates. Conversely, a PDA in preterm neonates causes significant clinical sequelae as a result from left to right shunting. It is widely recognized that a hemodynamically significant PDA is known to contribute to increased morbidity and mortality. The increase in pulmonary blood flow in the setting of prematurity leads to pulmonary edema, noncompliant lungs, and worsening of respiratory status. Other sequelae of a hemodynamically significant PDA include intraventricular hemorrhage, necrotizing enterocolitis, congestive heart failure, and failure to thrive.
Echocardiography is often used to evaluate hemodynamic significance of PDA. In general, pharmacological closure of PDA is less successful in infants with ductal diameter \>2mm. Lower ductal maximum velocity, which is usually associated with a larger PDA or higher pulmonary pressure, is another predictor of treatment failure .
The use of echocardiography to gather meaningful hemodynamic data often necessitates serial assessments that can be tedious and labor-intensive. Electrical cardiometry (EC) is a non-invasive, impedance-based monitor that provides absolute cardiac output estimates in clinical practice. Unlike echocardiography, EC is simple to apply, continuous in measurements and not operator dependent.
- Being tested
- I.V Paracetamol., Echocardiography., Electrical Cardiometry
- Keywords
- PDA, Electrical Cardiometry, hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I.V Paracetamol.Drug
Pharmacological thereby for hsPDA closure in the preterm neonates.
Echocardiography.Device
It is routinely performed in neonates for PDA screening and detection of any other cardiac anomalies.
Electrical CardiometryDevice
Non invasive hemodynamics monitoring
| Study group | Role | What they receive |
|---|---|---|
| Responders group: | included 26 preterm infants who successfully responded to medical PDA closure Receives: Drug: I.V Paracetamol.; Device: Echocardiography.; Device: Electrical Cardiometry | |
| Non responders group: | included 17 preterm infants who didn't respond to medical PDA closure Receives: Drug: I.V Paracetamol.; Device: Echocardiography.; Device: Electrical Cardiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume (SV)
Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: Stroke volume (SV): higher in non-responders.
Measured: 6 months
Cardiac output (CO)
Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: Cardiac output (CO): higher in non-responders.
Measured: 6 months
Systemic vascular resistance (SVR)
Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating:
Systemic vascular resistance (SVR): higher in responders.
Measured: 6 months
Total fluid content (TFC)
Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating:
- Total fluid content (TFC): higher in non-responders.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Oct 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus Arteriosus in Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Khaled Zidan, Tanta University
- Investigators
- Heba Elmahdy, Professor of Pediatrics, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606015
- Sponsor's protocol ID
- Hemodynamics with PDA closure
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Hemodynamics Assessment of Preterm Newborns With Successful Medical Closure of Patent Ductus Arteriosus
- ClinicalTrials.gov ID
- NCT06606015
- Acronym / sponsor ID
- Hemodynamics with PDA closure
- Keywords
- PDA, Electrical Cardiometry, hemodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 20 Sep 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 aim of our study was to use Electrical Cardiometry EC to monitor hemodynamic alternations during pharmacological closure of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm neonates
Detailed description
PDA in the first three days of life is a normal physiologic remnant in healthy term neonates. Conversely, a PDA in preterm neonates causes significant clinical sequelae as a result from left to right shunting. It is widely recognized that a hemodynamically significant PDA is known to contribute to increased morbidity and mortality. The increase in pulmonary blood flow in the setting of prematurity leads to pulmonary edema, noncompliant lungs, and worsening of respiratory status. Other sequelae of a hemodynamically significant PDA include intraventricular hemorrhage, necrotizing enterocolitis, congestive heart failure, and failure to thrive.
Echocardiography is often used to evaluate hemodynamic significance of PDA. In general, pharmacological closure of PDA is less successful in infants with ductal diameter \>2mm. Lower ductal maximum velocity, which is usually associated with a larger PDA or higher pulmonary pressure, is another predictor of treatment failure .
The use of echocardiography to gather meaningful hemodynamic data often necessitates serial assessments that can be tedious and labor-intensive. Electrical cardiometry (EC) is a non-invasive, impedance-based monitor that provides absolute cardiac output estimates in clinical practice. Unlike echocardiography, EC is simple to apply, continuous in measurements and not operator dependent.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders group: | – | Drug: I.V Paracetamol., Device: Echocardiography., Device: Electrical Cardiometryincluded 26 preterm infants who successfully responded to medical PDA closure |
| Non responders group: | – | Drug: I.V Paracetamol., Device: Echocardiography., Device: Electrical Cardiometryincluded 17 preterm infants who didn't respond to medical PDA closure |
Who may qualify
- Ages
- 24 hours to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study included 43 preterm neonates with hemodynamically significant PDA who received IV paracetamol as PDA medical closure. They were subdivided into 2 main groups responders and non responders to the PDA closure treatment.
Key inclusion criteria (1 listed)
- All preterm newborns who were admitted throughout the duration of the research.
Key exclusion criteria (5 listed)
- Newborn with congenital heart diseases.
- Newborn with acquired heart diseases (viral myocarditis)
- Newborn with dysrhythmias
- Newborn with symptomatic cardiac dysfunction secondary to extra cardiac diseases
- Newborn with significant pulmonary hypertension or systemic hypertension
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 |
|---|---|---|
| I.V Paracetamol.Pharmacological thereby for hsPDA closure in the preterm neonates. | Drug | Non responders group:, Responders group: |
| Echocardiography.It is routinely performed in neonates for PDA screening and detection of any other cardiac anomalies. | Device | Non responders group:, Responders group: |
| Electrical CardiometryNon invasive hemodynamics monitoring | Device | Non responders group:, Responders group: |
Primary outcome
Stroke volume (SV)
Time frame: 6 months
Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: Stroke volume (SV): higher in non-responders.
Cardiac output (CO)
Time frame: 6 months
Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: Cardiac output (CO): higher in non-responders.
Systemic vascular resistance (SVR)
Time frame: 6 months
Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: Systemic vascular resistance (SVR): higher in responders.
Total fluid content (TFC)
Time frame: 6 months
Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: 3. Total fluid content (TFC): higher in non-responders.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- 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. This study is not recruiting at the moment.
Heba Elmahdy, Professor of Pediatrics study director
Tanta University
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 Patent Ductus Arteriosus in Preterm Infants, run by Tanta University 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 5 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: finished, as of the sponsor's last update on 20 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke volume (SV) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2024.