NCT07561125 Effects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below
| NCT ID | NCT07561125 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | International Peace Maternity and Child Health Hospital |
| Condition | Bronchopulmonary Dysplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2026-04 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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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 29 participants in total. It began in 2026-04 with a primary completion date of 2027-09.
⚠ 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 short-term and long-term efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms born at 28 weeks and below. 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 ≤ 28 weeks + 6 days * Admission within 24 hours after birth. * Infants show a suspicion of BPD, the diagnosis is suspected based on the following clinical manifestations and chest X-ray findings. Clinical manifestations: Respiratory symptoms such as tachypnea (rapid breathing) and cyanosis, requiring respiratory support (including invasive, non-invasive, or oxygen therapy) to maintain oxygen saturation. Chest X-ray: Findings include increased bilateral lung markings or ground-glass opacities, and diffuse increased density in both lungs. Other possible causes such as infection or heart disease should be ruled out. • 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 NCT07561125 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, 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 NCT07561125 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 NCT07561125 currently recruiting?
Yes, NCT07561125 is actively recruiting participants. Contact the research team at fxmzj2004@163.com for enrollment information.
Where is the NCT07561125 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07561125 clinical trial?
NCT07561125 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 29 participants.