Actively Recruiting

Phase 2
Age: 0 - 10Weeks
All Genders
Healthy Volunteers
NCT06925360

IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

Led by International Peace Maternity and Child Health Hospital · Updated on 2026-04-01

20

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

Who Can Participate

Age: 0 - 10Weeks
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational age between 25 weeks and 29 weeks + 6 days
  • Admission within 24 hours after birth
  • Clinical symptoms and chest X-ray results highly suspect bronchopulmonary dysplasia, including respiratory signs developing days or weeks after birth such as shortness of breath, cyanosis, pulmonary rales, intermittent hypoxic attacks, and chronic oxygen dependence
  • Chest X-ray showing at least one of the following: lung texture thickening or ground glass opacity in early stage, diffuse lung texture blurred, lung hyperinflation, increased linear density shadows, or increased triangular density shadows under the pleura
  • Normal full-term newborn without history of severe lung diseases, birth asphyxia, hypoxic-ischemic encephalopathy, or other conditions affecting respiratory, nervous, or other systems development
Not Eligible

You will not qualify if you...

  • Major congenital anomalies such as congenital heart disease, craniocerebral deformity, structural respiratory abnormalities, or hereditary metabolic diseases
  • Chromosomal defects including trisomy 13, 18, or 21
  • Severe intracranial hemorrhage
  • Multiple organ failure
  • Severe lung infections
  • Other conditions deemed unsuitable for participation by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, China

Actively Recruiting

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Research Team

F

Fu Xuemei

CONTACT

L

Li Dan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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IVIG Trial for the Treatment of Bronchopulmonary Dysplasia | DecenTrialz