Congenital Heart Disease in Children Clinical Trial
Official title:
Left Ventricular Dysfunction Post Surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
Verified date | July 2019 |
Source | South Valley University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | October 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Months to 24 Months |
Eligibility |
Inclusion Criteria: - All cases had clinical as well as echocardiographic proof of hemodynamically critical PDA. Exclusion Criteria: - Patients with silent PDA. - irreversible pulmonary vascular disease. - those who had associated hemodynamically significant congenital heart disease (CHD). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
South Valley University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 % | echocardiography was done before PDA ligation; and follow up at one day, one month and six months post ligation. | |
Secondary | 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%. | all data were collected pre ligation; at one day, one month and six months post ligation |
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