Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-23 @ 8:57 PM
Study NCT ID:
NCT04801251
Status:
UNKNOWN
Last Update Posted:
2021-09-14
First Post:
2021-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Red Flags for Cardiac Examination for Early Detection of Congenital Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The relation between the presence of abnormal clinical cardiac findings and the abnormal echocardiographic findings'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2021-03-14', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Red flags for cardiac examination', 'timeFrame': '1 year', 'description': '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.\n\nMethods:\n\n1. 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.\n2. 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.'}, {'measure': 'The importance of history in detecting congenital heart disease', 'timeFrame': '1 year', 'description': "A full history will be taken, family history of congenital heart disease, mother's age and consanguinity, gravidity and parity should also be included.\n\nA 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.\n\nData 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.\n\nX\\^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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease']}, 'referencesModule': {'availIpds': [{'id': 'Sarah bakry', 'url': 'https://www.outlook.com/aun.edu.eg', 'type': 'Study Protocol', 'comment': 'All data or information will be uploaded on the website'}], 'references': [{'pmid': '27530200', 'type': 'RESULT', 'citation': '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': '23910039', 'type': 'RESULT', 'citation': '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': '27324366', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/22269840/', 'label': '\\[Pediatric cardiology and congenital heart disease: from fetus to adult\\]'}]}, 'descriptionModule': {'briefSummary': 'The study done to identify the relation between the presence of abnormal clinical cardiac findings and the echocardiographic findings in newborn infants.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Abnormal heart rate (\\< 90/min or \\< 160 per min )\n\n * Comfortable tachypnea ( RR \\> 60/min without other manifestations of respiratory distress)\n * Abnormal heart sounds (muffled, accentuated, single )\n * Abnormal precordial activity\n * Murmur: ( ≥ grade 3 intenisty, holosystolic timing, maximum intensity at upper left sternal border or with upright positing, diastolic murmur, harsh or blowing quality )\n * Abnormal oxygen saturation \\<90% in any extremity Oxygen saturation gradient \\> 3% difference in extremities.\n * Blood pressure gradient \\>10 mmHg higher in arms \\>10 mmHg lower in legs\n * Abnormal femoral pulses\n * Weakened pulses\n * Absent pulses\n * Hepatomegaly\n * Family history of cardiac disease\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT04801251', 'briefTitle': 'Red Flags for Cardiac Examination for Early Detection of Congenital Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Relation Between the Presence of Abnormal Clinical Cardiac Findings and Echocardiographic Findings in Newborn Infants', 'orgStudyIdInfo': {'id': 'Neonatal cardiology'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Resident', 'description': 'Full history.complete systemic and cardiac physical examination', 'interventionNames': ['Diagnostic Test: Echocardiographic examination']}, {'type': 'OTHER', 'label': 'Assistant Lecturer', 'description': 'Echocardiographic examination', 'interventionNames': ['Diagnostic Test: Echocardiographic examination']}], 'interventions': [{'name': 'Echocardiographic examination', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Full physical and cardiac examination'], 'description': 'Each patient included will undergo full cardiac physical examination and echocardiographic examination', 'armGroupLabels': ['Assistant Lecturer', 'Resident']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sarah Bakry, Resident', 'role': 'CONTACT', 'email': 'Sarabakry94@gmail.com', 'phone': '01129324744'}, {'name': 'Amira Shalaby, Lecturer', 'role': 'CONTACT', 'email': 'amirashalaby@aun.edu.eg', 'phone': '01223958949'}], 'overallOfficials': [{'name': 'Nagwa Ali, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Amira Shalaby, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'starting one year after publication', 'ipdSharing': 'YES', '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.', 'accessCriteria': 'all collected IPD, all IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Sarah Bakry Gaber Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}