An interventional study of Echocardiographic examination in Congenital Heart Disease, sponsored by Assiut University. Status unknown. Open to participants aged 1 Day to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-14.
Sponsored by Assiut University · Not applicable, Interventional, and Diagnostic
The study done to identify the relation between the presence of abnormal clinical cardiac findings and the echocardiographic findings in newborn infants.
A full history will be taken, complete general systemic and cardiac examination will be done. All patients with abnormal physical cardiac examination in the neonatal period (≤ 28 days of age) according to the inclusion criteria will have echocardiographic examination.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 1,779 interventional studies indexed under Heart Diseases.
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Abnormal heart rate (\< 90/min or \< 160 per min )
Exclusion Criteria:
Full history.complete systemic and cardiac physical examination
Diagnostic Test: Echocardiographic examination
Echocardiographic examination
Diagnostic Test: Echocardiographic examination
Each patient included will undergo full cardiac physical examination and echocardiographic examination
Also known as: Full physical and cardiac examination
Red flags for cardiac examination
A complete general systemic and cardiac examination will be done. All patients with abnormal physical cardiac examination in the neonatal period (≤ 28 days of age) according to the inclusion criteria will have echocardiographic examination. Methods: 1. Echocardiogram reports will be reviewed and cardiovascular abnormalities will be noted. The presence of patent ductus arteriosus (PDA) will be considered a normal finding if present at ≤ 7 days of age but not beyond. A patent foramen ovale will be considered normal. A small muscular ventricular septal defect (VSD), although common in neonates and, will be considered an abnormal finding. 2. All patients will have pulse oximeter screening, newborns with pulse oximetry ≥ 95% in the right hand or foot and ≤ 3% difference between the right hand and either foot at any time of testing have a normal result, and require no further testing.
Time frame: 1 year
The importance of history in detecting congenital heart disease
A full history will be taken, family history of congenital heart disease, mother's age and consanguinity, gravidity and parity should also be included. A File will be prepared for each neonate, which consist of demographic details including cardiac physical examination findings, birth weight, fetal age, history of folic acid intake by the mother, family history of cardiac disease, pulse oximeter screening, and results will be recorded. Data will be collected in form of taking history by interviewing questionnaire and full clinical examination will be done particularly cardiac examination and all findings will be recorded in patient clinical checklist. X\^2 will be used to compare frequencies among different categories. Student T test, ANOVA will be used to test differences between means. ALL statistical analysis will be performed by using the SPSS version 20. P value \<0.05 will be considered statistically significant for all applied statistical tests.
Time frame: 1 year
No study locations are listed for this record.
Plan to share: Yes — A full history will be taken, complete general systemic and cardiac examination will be done. All patients with abnormal physical cardiac examination in the neonatal period (≤ 28 days of age) according to the inclusion criteria will have echocardiographic examination.
Supporting information: Study protocol, Sap, Icf, Csr
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Assiut University