Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-04 @ 1:08 PM
Study NCT ID:
NCT05050851
Status:
UNKNOWN
Last Update Posted:
2021-09-21
First Post:
2020-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Parameters and Other Risk Factors Affecting Severity of Pneumonia in Children Under Five Years in Upper Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034141', 'term': 'Hypoalbuminemia'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D007019', 'term': 'Hypoproteinemia'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ratio of body mass index in patients with pneumonia', 'timeFrame': 'Day 1 assessment on hospital admission', 'description': 'we calculate height of patients in metres and weight in Kg then we divide the weight over the height square to get the body mass index'}], 'secondaryOutcomes': [{'measure': 'Concentration of Albumin in patients with pneumonia in g/dl', 'timeFrame': 'Day 1 assessment on hospital admission', 'description': 'blood samlpe will be taken for measuring Albumin level'}, {'measure': 'Hemoglobin level in patients with pnemonia in g/dl', 'timeFrame': 'Day 1 assessment on hospital admission', 'description': 'blood samlpe will be taken for measuring hemoglobin level'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pneumonia, nutrition, blood tests, body mass index'], 'conditions': ['Hypoalbuminemia', 'Stunted Growth', 'Anemia, Iron Deficiency']}, 'descriptionModule': {'briefSummary': 'Decrease mortality rate resulting from pneumonia', 'detailedDescription': "Recruiting patients with pneumonia admitted at Assiut University hospital . Then assessment of their condition and severity of pneumonia by examination and X-ray chest . After that, we aim at assessment their nutrition status and it's effect on severity of pneumonia. So we aim to investigate them by CBC, Albumin, CRP and CXR and correlate these parameters with the severity of pneumonia to assess the impact of nutrition on outcome of chest infections"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'children admitted at Assiut university children hospital below five years with diagnosis of pneumonia on admission.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of pneumonia on day 1 of hospital admission.\n\nExclusion Criteria:\n\n* patients with cardiac diseases\n* patients with immune deficiency disorders'}, 'identificationModule': {'nctId': 'NCT05050851', 'briefTitle': 'Nutritional Parameters and Other Risk Factors Affecting Severity of Pneumonia in Children Under Five Years in Upper Egypt', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Nutritional Parameters and Other Risk Factors Affecting Severity of Pneumonia in Children Under Five Years in Upper Egypt', 'orgStudyIdInfo': {'id': 'AOMSaid'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Measurement of nutritional parameters in children with pneumonia', 'type': 'DIETARY_SUPPLEMENT', 'description': 'measurement of Body Mass Index, head circumference, weight, length'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No identifiable data will be available to others apart from me as data collector'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident at Assiut University children hospital', 'investigatorFullName': 'Asmaa Omar Mahmoud Said', 'investigatorAffiliation': 'Assiut University'}}}}