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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04801251
• Other study ID #: Neonatal cardiology
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: Sarah Bakry, Resident
• Phone: 01129324744
• Email: Sarabakry94[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Diagnostic Test:
• Echocardiographic examination
Each patient included will undergo full cardiac physical examination and echocardiographic examination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Chitra N, Vijayalakshmi IB. Fetal echocardiography for early detection of congenital heart diseases. J Echocardiogr. 2017 Mar;15(1):13-17. doi: 10.1007/s12574-016-0308-2. Epub 2016 Aug 16. — View Citation

Hiremath G, Kamat D. When to call the cardiologist: treatment approaches to neonatal heart murmur. Pediatr Ann. 2013 Aug;42(8):329-33. doi: 10.3928/00904481-20130723-13. — View Citation

Triedman JK, Newburger JW. Trends in Congenital Heart Disease: The Next Decade. Circulation. 2016 Jun 21;133(25):2716-33. doi: 10.1161/CIRCULATIONAHA.116.023544. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   [Pediatric cardiology and congenital heart disease: from fetus to adult]