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.
• 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.

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
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
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) The Denver Developmental Screening Test primarily assesses the development of infants and young children aged 0-6 years across four domains: Personal-Social, Fine Motor-Adaptive, Language, and Gross Motor. It does not provide a direct "score." Instead, by observing whether a child can complete age-appropriate items, the results are ultimately classified into four categories: Normal, Suspect, Abnormal, and Untestable.	Corrected age/ chronological age of 6 months, 1 year, and 2 years
Tidal Breathing Flow-Volume Curve Parameters	Measurement of tidal breathing flow-volume curve (TBFV)-derived indices, with primary focus on TPTEF/TE (time to peak tidal expiratory flow to total expiratory time ratio) and VPTEF/VE (volume to peak tidal expiratory flow to total expiratory volume ratio)	Corrected age/ chronological age of 6 months, 1 year, and 2 years
Composite Clinical Assessment of Pulmonary Function Status	Categorization of overall pulmonary function status as Normal or Abnormal. As validated normative percentile references for TBFV-derived parameters are unavailable for preterm infants, classification is not based on fixed numerical cutoffs. Instead, the final determination is made through integrative clinical judgment combining: (a) quantitative analysis of TBFV curve parameters (TPTEF/TE and VPTEF/VE), (b) qualitative assessment of TBFV curve morphology (e.g., shape of the flow-volume trajectory, presence of expiratory flow limitation or concavity), and (c) concurrent clinical presentation (e.g., signs of respiratory distress, wheezing, oxygen requirement). The final Normal/Abnormal classification is assigned by the attending clinician based on comprehensive evaluation of all three domains.	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 (Actual): April 23, 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): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 21, 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