Effects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below

The Short-term and Long-term Effects of IVIG for Bronchopulmonary Dysplasia in Preterm Infant Born at 28 Weeks and Below

It is intended to examine the short-term and long-term efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms born at 28 weeks and below. 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): 29
• 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, 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 ≤ 28 weeks + 6 days
• Admission within 24 hours after birth.
• Infants show a suspicion of BPD, the diagnosis is suspected based on the following clinical manifestations and chest X-ray findings.

Clinical manifestations: Respiratory symptoms such as tachypnea (rapid breathing) and cyanosis, requiring respiratory support (including invasive, non-invasive, or oxygen therapy) to maintain oxygen saturation.

Chest X-ray: Findings include increased bilateral lung markings or ground-glass opacities, and diffuse increased density in both lungs. Other possible causes such as infection or heart disease should be ruled out.

• 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.	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
rate of BPD and severity classification at postmenstrual age (PMA) 36 weeks	Diagnostic Criteria for BPD: The 2018 National Institute of Child Health and Human Development (NICHD) diagnostic criteria will be applied, defining BPD in preterm infants born at <32 weeks GA as the presence of radiographically confirmed persistent parenchymal lung disease with a requirement for supplemental oxygen support (for ≥3 consecutive days) at PMA 36 weeks to maintain arterial oxygen saturation in the range of 90-95%.	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
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
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
Neurodevelopmental assessment	Neurodevelopmental testing (e.g., Denver Developmental Screening Test)	Corrected age/ chronological age of 6 months, 1 year, and 2 years

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 (Estimated): April 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: April 26, 2026
• First Submitted That Met QC Criteria: April 26, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

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-2026-032-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No