Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-30 @ 3:59 PM
Study NCT ID:
NCT06925360
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IVIG Trial for the Treatment of Bronchopulmonary Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-04-06', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age', 'timeFrame': '36 weeks of postmenstrual age', 'description': "For this trial, bronchopulmonary dysplasia was defined as an infant ≤32 weeks' gestational age with persistent radiographic findings of parenchymal lung disease who requires respiratory support at 36 weeks of postmenstrual age for ≥3 days to maintain arterial oxygen saturation 90%-95% ."}], 'secondaryOutcomes': [{'measure': 'duration of mechanical ventilation', 'timeFrame': 'until first discharge home or 36 weeks PMA', 'description': 'Defined as cumulative days on mechanical ventilation'}, {'measure': 'duration of O2 supplementation', 'timeFrame': 'until first discharge home or 36 weeks PMA', 'description': 'Defined as need for supplemental oxygen (mL/min flow or FiO2)'}, {'measure': 'Time to improvement in pulmonary imaging', 'timeFrame': 'until first discharge home or 36 weeks PMA'}, {'measure': 'Time to improvement in lung ultrasound imaging', 'timeFrame': 'until first discharge home or 36 weeks PMA'}, {'measure': 'Preterm birth complications', 'timeFrame': 'until first discharge home or 36 weeks PMA', 'description': 'Complications of preterm birth include retinopathy of prematurity, intraventricular hemorrhage, necrotizing enterocolitis, and septicemia et.al.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchopulmonary Dysplasia']}, 'descriptionModule': {'briefSummary': 'It is intended to examine the efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms. Participants will received continuous infusion IVIG 1 g/kg/day for the first 2 days, 0.5 g/kg/day for next 3 days (total does 3.5 g/kg), repeatable if necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age between 25 weeks and 29 weeks + 6 days\n* Admission within 24 hours after birth.\n* Clinical symptoms and chest X-ray results show a highly suspicion of BPD.Clinical symptoms develop in several days or weeks after birth, including respiratory symptoms and signs such as shortness of breath, cyanosis or pulmonary rales, intermittent hypoxic attacks, and chronic oxygen dependence (increased oxygen concentration and assisted ventilation) .One of the following signs present in chest X-ray: lung texture thickening or ground glass opacity in early stage, diffuse lung texture blurred, lung hyperinflation, shadow of linear density increased, and shadow of triangular density increased under the pleura.\n\nExclusion Criteria:\n\n* Major congenital anomalies(e.g., congenital heart disease, congenital craniocerebral deformity, congenital structural abnormality of respiratory system, congenital hereditary metabolic disease)\n* Chromosomal defects (e.g., trisomy 13, 18, 21)\n* Severe intracranial hemorrhage\n* Multiple organ failure\n* Infants who received hydrocortisone or other systemic glucocorticoids for at least 14 cumulative days or within 7 days before trial entry\n* With severe lung infections\n* Other circumstances that the investigator determines are not suitable for participation in this study'}, 'identificationModule': {'nctId': 'NCT06925360', 'briefTitle': 'IVIG Trial for the Treatment of Bronchopulmonary Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'International Peace Maternity and Child Health Hospital'}, 'officialTitle': 'The Efficacy of Intravenous Immunoglobulin for the Treatment of Bronchopulmonary Dysplasia', 'orgStudyIdInfo': {'id': 'GKLW-A-2024-114-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IVIG', 'interventionNames': ['Drug: intravenous immunoglobulin']}], 'interventions': [{'name': 'intravenous immunoglobulin', 'type': 'DRUG', 'description': '1 g/kg/day for the first 2 days, 0.5 g/kg/day for next 3 days (total does 3.5 g/kg), repeatable if necessary.', 'armGroupLabels': ['IVIG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng aiping', 'role': 'CONTACT', 'email': 'gfykyll@163.com', 'phone': '+86 021 64070434', 'phoneExt': '50407'}], 'facility': 'International Peace Maternity and Child Health Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Fu Xuemei', 'role': 'CONTACT', 'email': 'fxmzj2004@163.com', 'phone': '+86 18017313931'}, {'name': 'Li Dan', 'role': 'CONTACT', 'email': 'lidan910327@126.com', 'phone': '+86 18814100771'}], 'overallOfficials': [{'name': 'Fu Xuemei', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Peace Maternity and Child Health Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Peace Maternity and Child Health Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}