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

NCT04801251 | Unknown

• 1 other identifier: Neonatal cardiology
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (2)

• 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: 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.

  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

Study Arms (2)

Resident

OTHER

Full history.complete systemic and cardiac physical examination

Diagnostic Test: Echocardiographic examination

Assistant Lecturer

OTHER

Echocardiographic examination

Diagnostic Test: Echocardiographic examination

Interventions

Echocardiographic examination DIAGNOSTIC_TEST

Each patient included will undergo full cardiac physical examination and echocardiographic examination

Also known as: Full physical and cardiac examination

Assistant Lecturer; Resident

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 27530200 RESULT

• 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.

  PMID: 23910039 RESULT

• 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.

  PMID: 27324366 RESULT

Related Links

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

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nagwa Ali, Professor

  Assiut University

  STUDY DIRECTOR

• Amira Shalaby, Lecturer

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Sarah Bakry, Resident

CONTACT

01129324744; Sarabakry94@gmail.com

Amira Shalaby, Lecturer

CONTACT

01223958949; amirashalaby@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: The relation between the presence of abnormal clinical cardiac findings and the abnormal echocardiographic findings

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 16, 2021
• Study Start: October 20, 2021
• Primary Completion: October 20, 2022
• Study Completion: December 20, 2022
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: starting one year after publication
• Access Criteria: all collected IPD, all IPD that underlie results in a publication