NCT07561125

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
41mo left

Started Apr 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Sep 2029

Study Start

First participant enrolled

April 1, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

April 26, 2026

Last Update Submit

April 26, 2026

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • Pulmonary function testing

    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

  • +2 more secondary outcomes

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 immunoglobulinDRUG

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

Age1 Day - 10 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Fu Xuemei

    International Peace Maternity and Child Health Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fu Xuemei

CONTACT

+86 18017313931fxmzj2004@163.com

Li Dan

CONTACT

+86 18814100771lidan910327@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 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2029

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

CN(1)