search
Back to results

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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congenital Heart Disease

Eligibility Criteria

1 Day - 28 Days (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 8, 2021
    Last Updated
    September 10, 2021
    Sponsor
    Assiut University
    search

    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

    We'll reach out to this number within 24 hrs