About this trial
It is intended to examine the short-term and long-term efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms born at 28 weeks and below. 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Gestational age ≤ 28 weeks + 6 days
Admission within 24 hours after birth.
Clinical presentation and chest X radiograph changes of BPD
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
intravenous immunoglobulin
Drug1 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.
Treatment groups
Trial outcomes
Primary outcomes
Diagnosis of bronchopulmonary dysplasia and severity of the condition at 36 weeks of PMA
According to the diagnosis criteria published by National Institute of Child Health and Human Development in 2018, a premature infant (\<32 weeks'gestational age) with BPD has persistent parenchymal lung disease, radiographic confirmation of parenchymal lung disease, and at 36 weeks PMA requires 1 of the following FiO2 ranges/oxygen levels/O2 concentrations for ≥3 consecutive days to maintain arterial oxygen saturation in the 90%-95% range. (We have rephrased the title and description to better recapitulate the original intent of the IRB-approved protocol)
Secondary outcomes
duration of respiratory support
Defined as cumulative days on assisted ventilation, support with oxygen, or both
Preterm birth complications
Complications of preterm birth include retinopathy of prematurity, intraventricular hemorrhage, necrotizing enterocolitis, and septicemia et.al.
Neurodevelopmental assessment
Neurodevelopmental testing (e.g., Denver Developmental Screening Test) The Denver Developmental Screening Test primarily assesses the development of infants and young children aged 0-6 years across four domains: Personal-Social, Fine Motor-Adaptive, Language, and Gross Motor. It does not provide a direct "score." Instead, by observing whether a child can complete age-appropriate items, the results are ultimately classified into four categories: Normal, Suspect, Abnormal, and Untestable.
Weight
Sponsors and contacts
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