Status:
RECRUITING
IVIG Trial for the Treatment of Bronchopulmonary Dysplasia
Lead Sponsor:
International Peace Maternity and Child Health Hospital
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
Up to 10 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Gestational age between 25 weeks and 29 weeks + 6 days
- Admission within 24 hours after birth.
- 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.
Exclusion
- Major congenital anomalies(e.g., congenital heart disease, congenital craniocerebral deformity, congenital structural abnormality of respiratory system, congenital hereditary metabolic disease)
- Chromosomal defects (e.g., trisomy 13, 18, 21)
- Severe intracranial hemorrhage
- Multiple organ failure
- Infants who received hydrocortisone or other systemic glucocorticoids for at least 14 cumulative days or within 7 days before trial entry
- With severe lung infections
- Other circumstances that the investigator determines are not suitable for participation in this study
Key Trial Info
Start Date :
April 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06925360
Start Date
April 12 2025
End Date
December 1 2027
Last Update
December 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
International Peace Maternity and Child Health Hospital
Shanghai, Shanghai Municipality, China