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

NCT07561125 | Recruiting Phase 2

• 1 other identifier: GKLW-A-2026-032-01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• duration of respiratory support

  until first discharge home or 36 weeks PMA

• Preterm birth complications

  until first discharge home or 36 weeks PMA

• Neurodevelopmental assessment

  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

Study Arms (1)

IVIG

EXPERIMENTAL

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

Interventions

intravenous immunoglobulin DRUG

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.

IVIG

Eligibility Criteria

• Age: 1 Day - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age ≤ 28 weeks + 6 days
• Admission within 24 hours after birth.
• Clinical presentation and chest X radiograph changes of BPD
• Clinical presentation: The respiratory symptoms and signs developed within several days or weeks after birth, such as shortness of breath, cyanosis or pulmonary rales, intermittent hypoxic attacks, and chronic oxygen dependence that requires invasive or non-invasive respiratory supports or oxygen inhalation to maintain blood oxygen saturation.
• Chest X radiograph changes: The bilateral increased bronchovascular markings or ground-glass opacity and bilateral diffuse increased density, after the possible cause of other diseases such as infection and heart disease have been 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• International Peace Maternity and Child Health Hospital: lead

Study Sites (1)

International Peace Maternity and Child Health Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Fu Xuemei

  International Peace Maternity and Child Health Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fu Xuemei

CONTACT

+86 18017313931; fxmzj2004@163.com

Li Dan

CONTACT

+86 18814100771; lidan910327@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 1, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 23, 2026

Record last verified: 2026-04

Locations

CN (1)