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Clinical Trials/NCT04801251
NCT04801251
Unknown
Not Applicable

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

Assiut University0 sites70 target enrollmentOctober 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Assiut University
Enrollment
70
Primary Endpoint
The importance of history in detecting congenital heart disease
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2021
End Date
December 20, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Bakry Gaber Ahmed

Assistant Lecturer

Assiut University

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

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

Outcomes

Primary Outcomes

The importance of history in detecting congenital heart disease

Time Frame: 1 year

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.

Red flags for cardiac examination

Time Frame: 1 year

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: 1. 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. 2. 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.

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