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IVIG Trial for the Treatment of Bronchopulmonary Dysplasia | Clinical Trials | Clareo Health

RECRUITINGPHASE2

IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

The Efficacy of Intravenous Immunoglobulin for the Treatment of Bronchopulmonary Dysplasia

NCT06925360•International Peace Maternity and Child Health Hospital

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

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 12, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

January 30, 2026

Enrollment

ESTIMATED participants

Conditions

Bronchopulmonary Dysplasia

Interventions

intravenous immunoglobulin

DRUG

Contacts

Fu Xuemei

CONTACT

+86 18017313931 fxmzj2004@163.com

Li Dan

CONTACT

+86 18814100771 lidan910327@126.com

Reversibility of Bronchial Obstruction in Children Born Preterm

NCT06110481

Bronchopulmonary DysplasiaChronic Lung Disease of Prematurity+5 more

View study

RECRUITING

The Role of Volatile Organic Compounds (VOCs), Airway Mucins and the Microbiome in the Early Prediction of Bronchopulmonary Dysplasia (BPD)

NCT06342752

Bronchopulmonary Dysplasia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

Inclusion Criteria

Exclusion Criteria

Reversibility of Bronchial Obstruction in Children Born Preterm

The Role of Volatile Organic Compounds (VOCs), Airway Mucins and the Microbiome in the Early Prediction of Bronchopulmonary Dysplasia (BPD)

Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study

Comparison of INRECSURE and LISA in Preterm Neonates With RDS

Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia

Consequences of Antiangiogenic Factors Involved in Preeclampsia on Intra-uterine Growth Restricted Preterm Newborn