Clinical trial NCT04801251: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The relation between the presence of abnormal clinical cardiac findings and the abnormal echocardiographic findings
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Red flags for cardiac examination
timeFrame: 1 year
measure: The importance of history in detecting congenital heart disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Nagwa Ali, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Amira Shalaby, Lecturer
role: STUDY_DIRECTOR
References:
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.
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.
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.