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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04801251

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease	Diagnostic Test: Echocardiographic examination	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

The relation between the presence of abnormal clinical cardiac findings and the abnormal echocardiographic findingsThe relation between the presence of abnormal clinical cardiac findings and the abnormal echocardiographic findings

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Oct 20, 2021

Anticipated Primary Completion Date :

Oct 20, 2022

Anticipated Study Completion Date :

Dec 20, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Red flags for cardiac examination [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: 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.
The importance of history in detecting congenital heart disease [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 28 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Study Director: Nagwa Ali, Professor, Assiut University
Study Director: Amira Shalaby, Lecturer, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Sarah Bakry Gaber Ahmed, Assistant Lecturer, Assiut University

ClinicalTrials.gov Identifier:

NCT04801251

Other Study ID Numbers:

Neonatal cardiology

First Posted:

Mar 16, 2021

Last Update Posted:

Sep 14, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Diseases

Heart Defects, Congenital

Study Results

No Results Posted as of Sep 14, 2021