IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

Phase 2

Recruiting

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Drug: intravenous immunoglobulin

• Registration Number: NCT06925360
• Lead Sponsor: International Peace Maternity and Child Health Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-20
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-06
• Last Update Submitted: 2025-04-06
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-13
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IVIG	intravenous immunoglobulin	-

Primary Outcome Measures

Name	Time	Method
Survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age	36 weeks of postmenstrual age	For this trial, bronchopulmonary dysplasia was defined as an infant ≤32 weeks' gestational age with persistent radiographic findings of parenchymal lung disease who requires respiratory support at 36 weeks of postmenstrual age for ≥3 days to maintain arterial oxygen saturation 90%-95% .

Secondary Outcome Measures

Name	Time	Method
duration of O2 supplementation	until first discharge home or 36 weeks PMA	Defined as need for supplemental oxygen (mL/min flow or FiO2)
Time to improvement in pulmonary imaging	until first discharge home or 36 weeks PMA
Time to improvement in lung ultrasound imaging	until first discharge home or 36 weeks PMA
Preterm birth complications	until first discharge home or 36 weeks PMA	Complications of preterm birth include retinopathy of prematurity, intraventricular hemorrhage, necrotizing enterocolitis, and septicemia et.al.
duration of mechanical ventilation	until first discharge home or 36 weeks PMA	Defined as cumulative days on mechanical ventilation

Trial Locations

Locations (1)

International Peace Maternity and Child Health Hospital; 🇨🇳 Shanghai, Shanghai, China