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IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

Recruiting
10 years and younger
All
Phase 2

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Overview

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 1~2 times if necessary (5 days after the last infusion).

Eligibility

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

Study details
    Bronchopulmonary Dysplasia

NCT06925360

International Peace Maternity and Child Health Hospital

15 October 2025

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