Using IVIG to treat bronchopulmonary dysplasia in premature infants
The Efficacy of Intravenous Immunoglobulin for the Treatment of Bronchopulmonary Dysplasia
This study is testing if a special immune treatment called IVIG can help premature babies with breathing problems caused by bronchopulmonary dysplasia feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 10 Weeks |
| Sex | All |
| Sponsor | International Peace Maternity and Child Health Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06925360 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of intravenous immunoglobulin (IVIG) in treating bronchopulmonary dysplasia (BPD) in preterm infants. Participants will receive a continuous infusion of IVIG at a dosage of 1 g/kg/day for the first two days, followed by 0.5 g/kg/day for the next three days, with the possibility of repeating the treatment if necessary. The study focuses on infants who show clinical symptoms and chest X-ray results indicative of BPD shortly after birth. The goal is to determine whether IVIG can improve respiratory outcomes in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born between 25 weeks and 31 weeks + 6 days who exhibit symptoms of bronchopulmonary dysplasia shortly after birth.
Not a fit: Patients with major congenital anomalies or chromosomal defects are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve respiratory health and reduce complications in preterm infants with bronchopulmonary dysplasia.
How similar studies have performed: While the use of IVIG in this context is being explored, similar studies have shown promise in treating other conditions, making this approach potentially beneficial but not yet fully established.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Shanghai, Shanghai Municipality
- International Peace Maternity and Child Health Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Fu Xuemei — International Peace Maternity and Child Health Hospital
- Study coordinator: Fu Xuemei
- Email: fxmzj2004@163.com
- Phone: +86 18017313931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.