IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

The Efficacy of Intravenous Immunoglobulin for the Treatment of Bronchopulmonary Dysplasia

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchopulmonary Dysplasia
• Intervention / Treatment: Drug: intravenous immunoglobulin

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fu Xuemei; Phone Number: +86 18017313931; Email: fxmzj2004@163.com
• Study Contact Backup: Name: Li Dan; Phone Number: +86 18814100771; Email: lidan910327@126.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • International Peace Maternity and Child Health Hospital
      • Contact: Peng aiping; Phone Number: 50407 +86 021 64070434; Email: gfykyll@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 and chest X-ray changes 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVIG	Drug: intravenous 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of bronchopulmonary dysplasia and severity of the condition at 36 weeks of PMA	According to the diagnosis criteria published by National Institute of Child Health and Human Development in 2018, a premature infant (<32 weeks'gestational age) with BPD has persistent parenchymal lung disease, radiographic confirmation of parenchymal lung disease, and at 36 weeks PMA requires 1 of the following FiO2 ranges/oxygen levels/O2 concentrations for ≥3 consecutive days to maintain arterial oxygen saturation in the 90%-95% range. (We have rephrased the title and description to better recapitulate the original intent of the IRB-approved protocol)	36 weeks of postmenstrual age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm birth complications	Complications of preterm birth include retinopathy of prematurity, intraventricular hemorrhage, necrotizing enterocolitis, and septicemia et.al.	until first discharge home or 36 weeks PMA
Neurodevelopmental assessment	Neurodevelopmental testing (e.g., Denver Developmental Screening Test)	Corrected age/ chronological age of 6 months, 1 year, and 2 years.
Pulmonary function testing	Normal/Abnormal. Pulmonary function testing includes the following parameters: Breathing Frequency (BF), Inspiratory Time (TI)/ Expiratory Time Ratio (TE), Tidal Volume (VT), Time to Peak Tidal Expiratory Flow (TPTEF), Volume to Peak Tidal Expiratory Flow (VPTEF), etc. The determination of abnormal lung function in infants is primarily relies on the analysis of TPTEF/TE and VPTEF/VE ratios, the shape of the TBFV (Tidal Breathing Flow-Volume) loop, and the integration of clinical presentation.	Corrected age/ chronological age of 6 months, 1 year, and 2 years
Vision screening	Vision screening with Spot Vision Screener	Corrected age/ chronological age of 6 months, 1 year, and 2 years
Bone density measurement		Corrected age/ chronological age of 6 months, 1 year, and 2 years
Blood routine tests	Including white blood cell count, differential white blood cell count (such as neutrophils, lymphocytes, etc.), red blood cell count, hemoglobin concentration, platelet count, etc	Corrected age/ chronological age of 6 months, 1 year, and 2 years
Rehabilitation evaluation	e.g., Alberta Infant Motor Scale Assessment Report, 0-58 (min- max value), higher scores mean a better outcome.	Corrected age/ chronological age of 6 months and 1 year
Weight		Corrected age/ chronological age of 6 months, 1 year, and 2 years
Length		Corrected age/ chronological age of 6 months, 1 year, and 2 years
Head circumference		Corrected age/ chronological age of 6 months, 1 year, and 2 years
duration of respiratory support	Defined as cumulative days on assisted ventilation, support with oxygen, or both	until first discharge home or 36 weeks PMA

Collaborators and Investigators

• Sponsor: International Peace Maternity and Child Health Hospital
• Investigators: Principal Investigator: Fu Xuemei, International Peace Maternity and Child Health Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Ventilator-Induced Lung Injury; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bronchopulmonary Dysplasia; Amino Acids, Peptides, and Proteins; Proteins; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Immunoglobulin Isotypes; Immunoglobulin G; Immunoglobulins, Intravenous
• Other Study ID Numbers: GKLW-A-2024-114-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No