The Relation Between the Presence of Abnormal Clinical Cardiac Findings and Echocardiographic Findings in Newborn Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 主要终点
- The importance of history in detecting congenital heart disease
研究概览
简要总结
The study done to identify the relation between the presence of abnormal clinical cardiac findings and the echocardiographic findings in newborn infants.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• 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
排除标准
- •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
结局指标
主要结局
The importance of history in detecting congenital heart disease
时间窗: 1 year
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.
Red flags for cardiac examination
时间窗: 1 year
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.
次要结局
未报告次要终点
研究者
Sarah Bakry Gaber Ahmed
Assistant Lecturer
Assiut University