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IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

NCT ID: NCT06925360

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-12

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchopulmonary Dysplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IVIG

Group Type EXPERIMENTAL

intravenous immunoglobulin

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

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
* Infants who received hydrocortisone or other systemic glucocorticoids for at least 14 cumulative days or within 7 days before trial entry
* With severe lung infections
* Other circumstances that the investigator determines are not suitable for participation in this study
Maximum Eligible Age

10 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Peace Maternity and Child Health Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fu Xuemei

Role: PRINCIPAL_INVESTIGATOR

International Peace Maternity and Child Health Hospital

Locations

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International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fu Xuemei

Role: CONTACT

Phone: +86 18017313931

Email: [email protected]

Li Dan

Role: CONTACT

Phone: +86 18814100771

Email: [email protected]

Facility Contacts

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Peng aiping

Role: primary

Other Identifiers

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GKLW-A-2024-114-01

Identifier Type: -

Identifier Source: org_study_id