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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Diagnostic test: Echocardiographic examination

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Bakry, Resident; Phone Number: 01129324744; Email: Sarabakry94@gmail.com
• Study Contact Backup: Name: Amira Shalaby, Lecturer; Phone Number: 01223958949; Email: amirashalaby@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Resident; Full history.complete systemic and cardiac physical examination	Diagnostic test: Echocardiographic examination; Each patient included will undergo full cardiac physical examination and echocardiographic examination; Other Names: Full physical and cardiac examination
Other: Assistant Lecturer; Echocardiographic examination	Diagnostic test: Echocardiographic examination; Each patient included will undergo full cardiac physical examination and echocardiographic examination; Other Names: Full physical and cardiac examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
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.	1 year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Nagwa Ali, Professor, Assiut University; Study Director: Amira Shalaby, Lecturer, Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• [Pediatric cardiology and congenital heart disease: from fetus to adult]

Study record dates

Study Major Dates

• Study Start (Anticipated): October 20, 2021
• Primary Completion (Anticipated): October 20, 2022
• Study Completion (Anticipated): December 20, 2022

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 14, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: Neonatal cardiology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Study Data/Documents

1. Study Protocol
   Information identifier: Sarah bakry
   Information comments: All data or information will be uploaded on the website

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No