Actively Recruiting
The Short-term and Long-term Effects of IVIG for Bronchopulmonary Dysplasia in Preterm Infant Born at 28 Weeks and Below
Led by International Peace Maternity and Child Health Hospital · Updated on 2026-05-01
29
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the short-term and long-term effects of intravenous immunoglobulin (IVIG) in preterm infants born at 28 weeks gestation or earlier who show signs of bronchopulmonary dysplasia (BPD). The study aims to assess the safety and effectiveness of IVIG in reducing BPD severity and improving related health outcomes. This research is sponsored by the International Peace Maternity and Child Health Hospital and is a Phase 2 interventional trial. Participants will receive IVIG through continuous infusion at a dose of 1 g per kg per day for the first two days, followed by 0.5 g per kg per day for the next three days, totaling 3.5 g per kg. The treatment may be repeated if necessary. This dosing schedule is intended to evaluate the impact of IVIG on lung health in these vulnerable preterm infants. During the study, infants will be closely monitored for the rate and severity of BPD at 36 weeks postmenstrual age. Researchers will also track respiratory support duration, preterm birth complications, and growth and neurodevelopmental outcomes at corrected ages of 6 months, 1 year, and 2 years. Pulmonary function tests and measurements of weight, length, and head circumference will be performed during follow-up. The overall participation period extends to at least 2 years to observe long-term effects.
CONDITIONS
Brief Title
Effects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age 28 weeks and 6 days or less
- Admission to hospital within 24 hours after birth
- Suspicion of bronchopulmonary dysplasia based on respiratory symptoms and chest X-ray findings
- Normal full-term newborns without history of severe lung disease or conditions affecting respiratory or nervous system development
You will not qualify if you...
- Major congenital anomalies such as heart disease or structural respiratory abnormalities
- Chromosomal defects including trisomy 13, 18, or 21
- Severe intracranial hemorrhage
- Multiple organ failure
- Severe lung infections
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days or longer if repeated
Participants receive intravenous immunoglobulin with dosing of 1 g/kg/day for the first 2 days, then 0.5 g/kg/day for the next 3 days, which may be repeated if necessary.
Daily visits for up to 5 days
Duration - Up to 2 years
Participants are monitored for respiratory support duration, preterm birth complications, and undergo neurodevelopmental and pulmonary assessments at corrected ages of 6 months, 1 year, and 2 years.
Visits at 6 months, 1 year, and 2 years corrected age
Trial Site Locations
Total: 1 location
1
International Peace Maternity and Child Health Hospital
Shanghai, China
Actively Recruiting
Research Team
F
Fu Xuemei
L
Li Dan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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