NCT06925360

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 if necessary.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
19mo left

Started Apr 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Apr 2025Dec 2027

First Submitted

Initial submission to the registry

March 20, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

April 12, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 1, 2026

Status Verified

November 1, 2025

Enrollment Period

2.6 years

First QC Date

March 20, 2025

Last Update Submit

March 27, 2026

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

  • Survival without bronchopulmonary dysplasia at 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% .

    36 weeks of postmenstrual age

Secondary Outcomes (11)

  • 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

  • Vision screening

    Corrected age/ chronological age of 6 months, 1 year, and 2 years

  • +6 more secondary outcomes

Study Arms (1)

IVIG

EXPERIMENTAL
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

AgeUp to 10 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age between 25 weeks and 29 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.
  • 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, Shanghai Municipality, 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

March 20, 2025

First Posted

April 13, 2025

Study Start

April 12, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 1, 2026

Record last verified: 2025-11

Locations

CN(1)