Clinical trial NCT06925360: IVIG Trial for the Treatment of Bronchopulmonary Dysplasia
Official title: The Efficacy of Intravenous Immunoglobulin for the Treatment of Bronchopulmonary Dysplasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Bronchopulmonary Dysplasia
Lead sponsor: International Peace Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 10
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 1\~2 times if necessary (5 days after the last infusion).


Eligibility criteria: Inclusion Criteria:

* Gestational age between 25 weeks and 31 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

Primary outcomes:
measure: Survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age
timeFrame: 36 weeks of postmenstrual age
Secondary outcomes:
measure: duration of mechanical ventilation
timeFrame: until first discharge home or 36 weeks PMA
measure: duration of O2 supplementation
timeFrame: until first discharge home or 36 weeks PMA
measure: Time to improvement in pulmonary imaging
timeFrame: until first discharge home or 36 weeks PMA
measure: Time to improvement in lung ultrasound imaging
timeFrame: until first discharge home or 36 weeks PMA
measure: Preterm birth complications
timeFrame: until first discharge home or 36 weeks PMA
Other outcomes:
Locations:
city: Shanghai
country: China
facility: International Peace Maternity and Child Health Hospital
state: Shanghai
Study officials:
affiliation: International Peace Maternity and Child Health Hospital
name: Fu Xuemei
role: PRINCIPAL_INVESTIGATOR
References: