Study of IVIG Treatment Effects on Bronchopulmonary Dysplasia in Preterm Infants Born at 28 Weeks or Earlier

What this Trial Is About

Researchers are evaluating the short-term and long-term effects of intravenous immunoglobulin IVIG treatment for bronchopulmonary dysplasia BPD in preterm infants born at 28 weeks gestational age or earlier. This Phase 2 trial aims to understand both the safety and efficacy of this treatment in this vulnerable population. The study focuses on infants who show clinical signs of BPD and characteristic chest X-ray changes, with the goal of improving respiratory outcomes. Participants receive IVIG as a continuous infusion at a dose of 1 gkgday for the first two days, followed by 0.5 gkgday for the next three days, totaling 3.5 gkg. This treatment regimen can be repeated if necessary. The study does not include a comparison group and is designed as a single-group intervention trial. Throughout the study, participants are closely monitored for diagnosis and severity of BPD at 36 weeks postmenstrual age. Secondary measures include duration of respiratory support, complications related to preterm birth, and comprehensive neurodevelopmental assessments at corrected ages of 6 months, 1 year, and 2 years. Growth parameters such as weight, length, head circumference, pulmonary function, and clinical lung assessments are also tracked. The total participation spans from birth through two years of age, ensuring thorough safety and outcome evaluation.

Effects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below