Congenital Heart Disease in ChildrenNCT04018079
Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
An observational study of Congenital Heart Disease in Children, run by South Valley University.
Trial summary
Background: PDA is viewed as a standout amongst the most widely recognized congenital heart defects in children and its closure is responsible for many hemodynamic changes that require intervention and care. Read more about this study
- Who is it for?
- Ages 8 to 24 months
- Conditions the study is for
- Congenital Heart Disease in Children
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 30 Oct 2018
- How long will I take part?
- 6 Months
- 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 8 to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: All cases were operated in cardiothoracic surgery department and were followed up by cardiothoracic surgeons and paediatricians at cardiac surgery ICU, Qena University Hospital.
Who may be able to join
- All cases had clinical as well as echocardiographic proof of hemodynamically critical PDA.
Who cannot join
- Patients with silent PDA.
- irreversible pulmonary vascular disease.
- those who had associated hemodynamically significant congenital heart disease (CHD).
About this study
Official title: Left Ventricular Dysfunction Post Surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
Background:
PDA is viewed as a standout amongst the most widely recognized congenital heart defects in children and its closure is responsible for many hemodynamic changes that require intervention and care.
Methods:
A retrospective study included fifty children with isolated PDA treated by surgical ligation from June 2015 to June 2018. Their mean age was 15.78 ± 7.58 months and 72% were females. The LV dimensions and systolic function were assessed by two-dimensional echocardiography pre PDA ligation. The mean duct size was 4.08 ± 1.25 mm.
Read the detailed description
Methods:
Study population Fifty children with PDA, for whom surgical PDA ligation was done from June 2015 to June 2018. All cases were operated in cardiothoracic surgery department and were followed up by cardiothoracic surgeons and paediatricians at cardiac surgery ICU, Qena University Hospital. Their mean age at intervention was 15.78 ± 7.58 months, body surface area (BSA) 0.43±0.03 and 32 (72%) were females. The mean duct diameter was 4.08 ± 1.25 mm. The study conforms to the ethical standards of the Helsinki Declaration and approval was obtained from the institutional ethics committee of Qena Faculty of Medicine.
Surgical technique PDA ligation was performed under general anaesthesia after pre-operative anaesthetic evaluation. After single endotracheal tube anaesthesia induction; children were placed on the right lateral recumbent position fixed with adhesive plaster and a pad under the chest, the left arm raised above the head. A left mini-thoracotomy incision is done parallel to the medial border of the scapula and entrance to the thoracic cavity was via the third or fourth intercostal space. Cautiously, the ductus is identified and dissected carefully. Then it was doubly ligated with silk ligature (2/0 or 0). An intercostal tube inserted during operation and removed within 48 hours if no drainage presents.
Descriptive statistical analysis Data were arranged and analyzed utilizing Version 20 of the SPSS program (Statistical Package for Social Sciences). Continuous variables were compared using the Student paired t-test and are expressed as mean values ± standard deviation. Pearson Chi-Square tests were used to detect differences among groups for categorical variables. The relationship between PDA size and changes in echocardiographic parameters was verified using the Pearson linear correlation and the linear regression analysis. P-value of <0.05 was considered of significance.
- Conditions
- Congenital Heart Disease in Children
- Keywords
- PDA, Echo
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between the echocardiographic changes before PDA ligation to the follow up changes at one day, one month and six months post PDA ligation.
the echocardiographic data included: The LV end-diastolic dimension (LVEDd) in mm, LV end-systolic dimension (LVESd) in mm, PDA size in mm, left atrial to aortic diameter ratio (LA/Ao ratio), EF % and FS %
Measured: echocardiography was done before PDA ligation; and follow up at one day, one month and six months post ligation.
Secondary outcomes (1)
identification of the preoperative predictor factors of LV dysfunction following PDA surgical ligation in children
we classified our patients into two gatherings as indicated by FS % based on a definition of LV systolic dysfunction; group I with FS ≤ 29% and group II with FS > 29%.
Measured: all data were collected pre ligation; at one day, one month and six months post ligation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Jun 2015
- Primary completion30 Jun 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease in ChildrenStudies 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
- Other
- Enrolment
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel Bary Ahmed Ibrahim, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018079
- Sponsor's protocol ID
- South Valley University 1513
- Status last verified
- Jul 2019
- First submitted
- 3 Jun 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdel-Bary M, Abdel-Baseer KA, Abdel-Latif AF, Abdel-Naser MA, Nafie M, Eisa KM. Left ventricular dysfunction postsurgical patent ductus arteriosus ligation in children: predictor factors analysis. J Cardiothorac Surg. 2019 Sep 18;14(1):168. doi: 10.1186/s13019-019-0990-z.
PubMed 31533759
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Dysfunction Post Surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
- ClinicalTrials.gov ID
- NCT04018079
- Acronym / sponsor ID
- South Valley University 1513
- Conditions
- Congenital Heart Disease in Children
- Keywords
- PDA, Echo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 12 Jul 2019 (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.
Background:
PDA is viewed as a standout amongst the most widely recognized congenital heart defects in children and its closure is responsible for many hemodynamic changes that require intervention and care.
Methods:
A retrospective study included fifty children with isolated PDA treated by surgical ligation from June 2015 to June 2018. Their mean age was 15.78 ± 7.58 months and 72% were females. The LV dimensions and systolic function were assessed by two-dimensional echocardiography pre PDA ligation. The mean duct size was 4.08 ± 1.25 mm.
Detailed description
Methods:
Study population Fifty children with PDA, for whom surgical PDA ligation was done from June 2015 to June 2018. All cases were operated in cardiothoracic surgery department and were followed up by cardiothoracic surgeons and paediatricians at cardiac surgery ICU, Qena University Hospital. Their mean age at intervention was 15.78 ± 7.58 months, body surface area (BSA) 0.43±0.03 and 32 (72%) were females. The mean duct diameter was 4.08 ± 1.25 mm. The study conforms to the ethical standards of the Helsinki Declaration and approval was obtained from the institutional ethics committee of Qena Faculty of Medicine.
Surgical technique PDA ligation was performed under general anaesthesia after pre-operative anaesthetic evaluation. After single endotracheal tube anaesthesia induction; children were placed on the right lateral recumbent position fixed with adhesive plaster and a pad under the chest, the left arm raised above the head. A left mini-thoracotomy incision is done parallel to the medial border of the scapula and entrance to the thoracic cavity was via the third or fourth intercostal space. Cautiously, the ductus is identified and dissected carefully. Then it was doubly ligated with silk ligature (2/0 or 0). An intercostal tube inserted during operation and removed within 48 hours if no drainage presents.
Descriptive statistical analysis Data were arranged and analyzed utilizing Version 20 of the SPSS program (Statistical Package for Social Sciences). Continuous variables were compared using the Student paired t-test and are expressed as mean values ± standard deviation. Pearson Chi-Square tests were used to detect differences among groups for categorical variables. The relationship between PDA size and changes in echocardiographic parameters was verified using the Pearson linear correlation and the linear regression analysis. P-value of <0.05 was considered of significance.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 8 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All cases were operated in cardiothoracic surgery department and were followed up by cardiothoracic surgeons and paediatricians at cardiac surgery ICU, Qena University Hospital.
Key inclusion criteria (1 listed)
- All cases had clinical as well as echocardiographic proof of hemodynamically critical PDA.
Key exclusion criteria (3 listed)
- Patients with silent PDA.
- irreversible pulmonary vascular disease.
- those who had associated hemodynamically significant congenital heart disease (CHD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison between the echocardiographic changes before PDA ligation to the follow up changes at one day, one month and six months post PDA ligation.
Time frame: echocardiography was done before PDA ligation; and follow up at one day, one month and six months post ligation.
the echocardiographic data included: The LV end-diastolic dimension (LVEDd) in mm, LV end-systolic dimension (LVESd) in mm, PDA size in mm, left atrial to aortic diameter ratio (LA/Ao ratio), EF % and FS %
1 secondary outcome
identification of the preoperative predictor factors of LV dysfunction following PDA surgical ligation in children
Time frame: all data were collected pre ligation; at one day, one month and six months post ligation
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 12 Jul 2019.
- Derived from this study: PubMed 31533759Abdel-Bary M, Abdel-Baseer KA, Abdel-Latif AF, Abdel-Naser MA, Nafie M, Eisa KM. Left ventricular dysfunction postsurgical patent ductus arteriosus ligation in children: predictor factors analysis. J Cardiothorac Surg. 2019 Sep 18;14(1):168. doi: 10.1186/s13019-019-0990-z.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease in Children, run by South Valley University.
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 3 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 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison between the echocardiographic changes before PDA ligation to the follow up changes at one day, one month and six months post PDA ligation. (time frame: echocardiography was done before PDA ligation; and follow up at one day, one month and six months post ligation.). 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 NCT04018079, which also lists 1 linked publication.
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 12 Jul 2019.