Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 2:59 AM
Study NCT ID:
NCT07366593
Status:
RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Profile and Respiratory Parameters in Down Syndrome Children With Acute Pneumonia: Pre-Intervention Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-16', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum IgG, IgA, IgM', 'timeFrame': 'Upon enrollment and prior to any intervention baseline data were collected', 'description': 'Immunoglobulins: Concentrations of IgG(mg/dl) IgA,(mg/dl) and IgM (mg/dl) were determined from serum using an automated nephelometer'}, {'measure': 'Respiratory Rate', 'timeFrame': 'Upon enrollment and prior to any intervention baseline data were collected', 'description': 'Respiratory rate (breaths/minute) was determined by direct observation and counting of chest wall movements over one full minute'}, {'measure': 'Arterial Oxygen Saturation (SaO2)', 'timeFrame': 'Upon enrollment and prior to any intervention baseline data were collected', 'description': 'Peripheral oxygen saturation (%) was measured non-invasively via pulse oximetry'}, {'measure': 'White Blood Cell count', 'timeFrame': 'Upon enrollment and prior to any intervention baseline data were collected', 'description': 'Total WBC count (thousands/mm³) was measured from a whole blood sample using an ADVIA 120 automated hematology analyzer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Down Syndrome, pneumonia, immune, oxygen saturation'], 'conditions': ['Down Syndrome']}, 'descriptionModule': {'briefSummary': 'Baseline serum IgG, IgA, IgM (nephelometry), total WBC count (automated analyzer), RR (manual count), and SaO2 (pulse oximetry) were measured. Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age', 'detailedDescription': 'descriptive, cross-sectional study analyzed baseline data from 40 children with DS and acute pneumonia enrolled prior to intervention in a larger trial. Baseline serum IgG, IgA, IgM (nephelometry), total WBC count (automated analyzer), RR (manual count), and SaO2 (pulse oximetry) were measured. Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Data collection occurred at the inpatient pediatric ward of King Abdulaziz University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Down Syndrome with acute bronchopneumonia\n* sufficient cognitive ability\n\nExclusion Criteria:\n\n* severe congenital heart defects\n* primary immunodeficiencies'}, 'identificationModule': {'nctId': 'NCT07366593', 'briefTitle': 'Immune Profile and Respiratory Parameters in Down Syndrome Children With Acute Pneumonia: Pre-Intervention Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Badr University'}, 'officialTitle': 'Relationship Between Immune Profile and Respiratory Parameters in Down Syndrome Children With Acute Pneumonia: Pre-Intervention Analysis', 'orgStudyIdInfo': {'id': 'Down Syndrome Children'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age', 'type': 'PROCEDURE', 'description': 'Baseline serum IgG, IgA, IgM (nephelometry), total WBC count (automated analyzer), RR (manual count), and SaO2 (pulse oximetry) were measured. Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mona Abdelkhalek, Phd', 'role': 'CONTACT'}], 'facility': 'Badr university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mona Abdelkhalek, assistance prof', 'role': 'CONTACT', 'email': '3m.sons@gmail.com', 'phone': '002021024056108'}], 'facility': 'Mona Mohamed Abdelkhalek', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mona Mohamed Abdelkhalek, assistance prof', 'role': 'CONTACT', 'email': '3m.sons@gmail.com', 'phone': '002021024056108'}, {'name': 'Mona Mohamed Abdelkhalek, assistance prof', 'role': 'CONTACT', 'email': 'Mona.Abdelkhalek@buc.edu.eg', 'phone': '002021024056108'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The investigators have not yet determined whether individual participant data will be shared. Any future decision will depend on institutional policies, ethical considerations, and applicable data protection regulations."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Badr University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistance professor', 'investigatorFullName': 'Mona Mohamed Abdelkhalek', 'investigatorAffiliation': 'Badr University'}}}}