RecruitingPhase 2NCT06925360

IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

The Efficacy of Intravenous Immunoglobulin for the Treatment of Bronchopulmonary Dysplasia


Sponsor

International Peace Maternity and Child Health Hospital

Enrollment

20 participants

Start Date

Apr 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

Max Age: 10 Weeks

Inclusion Criteria4

  • 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 Criteria6

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGintravenous immunoglobulin

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.


Locations(1)

International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06925360


Related Trials