Study on Intravenous Immunoglobulin IVIG Treatment for Bronchopulmonary Dysplasia in Preterm Infants

What this Trial Is About

This research aims to evaluate the efficacy and safety of intravenous immunoglobulin IVIG for treating bronchopulmonary dysplasia BPD in premature infants. The study focuses on infants born between 25 and 29 weeks plus 6 days of gestational age who show clinical signs and chest X-ray evidence suggestive of BPD. It is a phase 2 clinical trial sponsored by the International Peace Maternity and Child Health Hospital. Participants will receive an IVIG treatment regimen consisting of a continuous infusion of 1 gkgday for the first two days, followed by 0.5 gkgday for the next three days, totaling 3.5 gkg. This treatment may be repeated if necessary. The study does not include a placebo or comparator group and has no blinding. Throughout the study, infants will be monitored for the diagnosis and severity of BPD at 36 weeks postmenstrual age. Secondary assessments include the duration of respiratory support, complications related to preterm birth, and various developmental evaluations such as neurodevelopment, pulmonary function, vision, bone density, blood tests, rehabilitation progress, weight, length, and head circumference measured at corrected ages of 6 months, 1 year, and 2 years. The total follow-up period extends up to 2 years to track these outcomes and safety.

IVIG Trial for the Treatment of Bronchopulmonary Dysplasia