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

A

Assiut University

Status

Unknown

Conditions

Congenital Heart Disease

Treatments

Diagnostic Test: Echocardiographic examination

Study type

Interventional

Funder types

Other

Identifiers

NCT04801251
Neonatal cardiology

Details and patient eligibility

About

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

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

1 to 28 days old

Volunteers

Accepts 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Resident
Other group
Description:
Full history.complete systemic and cardiac physical examination
Treatment:
Diagnostic Test: Echocardiographic examination
Assistant Lecturer
Other group
Description:
Echocardiographic examination
Treatment:
Diagnostic Test: Echocardiographic examination

Trial contacts and locations

0

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Central trial contact

Amira Shalaby, Lecturer; Sarah Bakry, Resident

Data sourced from clinicaltrials.gov

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