NCT06925360 IVIG Trial for the Treatment of Bronchopulmonary Dysplasia
| NCT ID | NCT06925360 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | International Peace Maternity and Child Health Hospital |
| Condition | Bronchopulmonary Dysplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-04-12 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-04-12 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 the first 2 days, 0.5 g/kg/day for next 3 days (total does 3.5 g/kg), repeatable if necessary.
Eligibility Criteria
Inclusion Criteria: * 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 and chest X-ray changes 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. * A normal full-term newborn without a history of severe lung diseases, birth asphyxia, hypoxic-ischemic encephalopathy or other conditions that may affect the development of the respiratory, nervous and other systems. Exclusion Criteria: * 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 * With severe lung infections * Other circumstances that the investigator determines are not suitable for participation in this study
Contact & Investigator
Fu Xuemei
PRINCIPAL INVESTIGATOR
International Peace Maternity and Child Health Hospital
Frequently Asked Questions
Who can join the NCT06925360 clinical trial?
This trial is open to participants of all sexes, up to 10 Weeks, studying Bronchopulmonary Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06925360 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06925360 currently recruiting?
Yes, NCT06925360 is actively recruiting participants. Contact the research team at fxmzj2004@163.com for enrollment information.
Where is the NCT06925360 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06925360 clinical trial?
NCT06925360 is sponsored by International Peace Maternity and Child Health Hospital. The principal investigator is Fu Xuemei at International Peace Maternity and Child Health Hospital. The trial plans to enroll 20 participants.