IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

Launched by INTERNATIONAL PEACE MATERNITY AND CHILD HEALTH HOSPITAL · Apr 6, 2025

Keywords

ClinConnect Summary

The IVIG Trial for the Treatment of Bronchopulmonary Dysplasia is studying a treatment called intravenous immunoglobulin (IVIG) to see if it can help premature babies with a condition known as bronchopulmonary dysplasia (BPD). BPD can make it hard for these babies to breathe, and it often develops in the first few weeks after birth. In this trial, eligible infants—those born between 25 weeks and 31 weeks and who show signs of BPD shortly after birth—will receive IVIG through an IV for a total of five days, with the option to repeat the treatment if needed.

To participate, babies must be admitted to the hospital within 24 hours of birth and have specific symptoms and chest X-ray results that suggest BPD. However, babies with certain serious health issues or congenital conditions cannot join the study. This trial is currently recruiting participants of all genders, and it aims to find out if IVIG is safe and effective for these vulnerable infants. If your baby qualifies, you can expect close monitoring and care throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Gestational age between 25 weeks and 31 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 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
• • 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