Red Flags for Cardiac Examination for Early Detection of Congenital Heart Disease
Primary Purpose
Congenital Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Echocardiographic examination
Sponsored by
About this trial
This is an interventional diagnostic trial for Congenital Heart Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Resident
Assistant Lecturer
Arm Description
Full history.complete systemic and cardiac physical examination
Echocardiographic examination
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04801251
Brief Title
Red Flags for Cardiac Examination for Early Detection of Congenital Heart Disease
Official Title
The Relation Between the Presence of Abnormal Clinical Cardiac Findings and Echocardiographic Findings in Newborn Infants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2021 (Anticipated)
Primary Completion Date
October 20, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study done to identify the relation between the presence of abnormal clinical cardiac findings and the echocardiographic findings in newborn infants.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The relation between the presence of abnormal clinical cardiac findings and the abnormal echocardiographic findings
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resident
Arm Type
Other
Arm Description
Full history.complete systemic and cardiac physical examination
Arm Title
Assistant Lecturer
Arm Type
Other
Arm Description
Echocardiographic examination
Intervention Type
Diagnostic Test
Intervention Name(s)
Echocardiographic examination
Other Intervention Name(s)
Full physical and cardiac examination
Intervention Description
Each patient included will undergo full cardiac physical examination and echocardiographic examination
Primary Outcome Measure Information:
Title
Red flags for cardiac examination
Description
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.
Time Frame
1 year
Title
The importance of history in detecting congenital heart disease
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Bakry, Resident
Phone
01129324744
Email
Sarabakry94@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amira Shalaby, Lecturer
Phone
01223958949
Email
amirashalaby@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagwa Ali, Professor
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amira Shalaby, Lecturer
Organizational Affiliation
Assiut University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan 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.
IPD Sharing Time Frame
starting one year after publication
IPD Sharing Access Criteria
all collected IPD, all IPD that underlie results in a publication
Citations:
PubMed Identifier
27530200
Citation
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.
Results Reference
result
PubMed Identifier
23910039
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. No abstract available.
Results Reference
result
PubMed Identifier
27324366
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. No abstract available.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/22269840/
Description
[Pediatric cardiology and congenital heart disease: from fetus to adult]
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.outlook.com/aun.edu.eg
Available IPD/Information Identifier
Sarah bakry
Available IPD/Information Comments
All data or information will be uploaded on the website
Learn more about this trial
Red Flags for Cardiac Examination for Early Detection of Congenital Heart Disease
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