Red Flags for Cardiac Examination for Early Detection of Congenital Heart Disease

Study Overview
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Brief Summary
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The study done to identify the relation between the presence of abnormal clinical cardiac findings and the echocardiographic findings in newborn infants.

Detailed Description
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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.

Official Title
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The Relation Between the Presence of Abnormal Clinical Cardiac Findings and Echocardiographic Findings in Newborn Infants

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Diagnostic Test: Echocardiographic examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Abnormal heart rate (< 90/min or < 160 per min ) Comfortable tachypnea ( RR > 60/min without other manifestations of respiratory distress) Abnormal heart sounds (muffled, accentuated, single ) Abnormal precordial activity Murmur: ( ≥ grade 3 intenisty, holosystolic timing, maximum intensity at upper left sternal border or with upright positing, diastolic murmur, harsh or blowing quality ) Abnormal oxygen saturation <90% in any extremity Oxygen saturation gradient > 3% difference in extremities. Blood pressure gradient >10 mmHg higher in arms >10 mmHg lower in legs Abnormal femoral pulses Weakened pulses Absent pulses Hepatomegaly Family history of cardiac disease Exclusion Criteria: Newborns with disorders affecting the heart as anemia, septicemia, respiratory disorders as respiratory distress syndrome, pneumonia, hypoplastic lung, renal impairment, hypertension, metabolic disease, syndromatic CHF

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The relation between the presence of abnormal clinical cardiac findings and the abnormal echocardiographic findings
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Resident<br>Full history.complete systemic and cardiac physical examination | Diagnostic Test: Echocardiographic examination<br>* Each patient included will undergo full cardiac physical examination and echocardiographic examination<br>* Other names: Full physical and cardiac examination;|
| Other: Assistant Lecturer<br>Echocardiographic examination | Diagnostic Test: Echocardiographic examination<br>* Each patient included will undergo full cardiac physical examination and echocardiographic examination<br>* Other names: Full physical and cardiac examination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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. 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. | 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. | 1 year |