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

NCT ID: NCT04801251

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-20

Study Completion Date

2022-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The relation between the presence of abnormal clinical cardiac findings and the abnormal echocardiographic findings
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resident

Full history.complete systemic and cardiac physical examination

Group Type OTHER

Echocardiographic examination

Intervention Type DIAGNOSTIC_TEST

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

Assistant Lecturer

Echocardiographic examination

Group Type OTHER

Echocardiographic examination

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Echocardiographic examination

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Full physical and cardiac examination

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sarah Bakry Gaber Ahmed

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nagwa Ali, Professor

Role: STUDY_DIRECTOR

Assiut University

Amira Shalaby, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sarah Bakry, Resident

Role: CONTACT

01129324744

Amira Shalaby, Lecturer

Role: CONTACT

01223958949

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 27530200 (View on PubMed)

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.

Reference Type RESULT
PMID: 23910039 (View on PubMed)

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.

Reference Type RESULT
PMID: 27324366 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Study Protocol

All data or information will be uploaded on the website

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://pubmed.ncbi.nlm.nih.gov/22269840/

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Neonatal cardiology

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.