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.
Infants show a suspicion of BPD, the diagnosis is suspected based on the following clinical manifestations and chest X-ray findings.
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
rate of BPD and severity classification at postmenstrual age (PMA) 36 weeks
Diagnostic Criteria for BPD: The 2018 National Institute of Child Health and Human Development (NICHD) diagnostic criteria will be applied, defining BPD in preterm infants born at \<32 weeks GA as the presence of radiographically confirmed persistent parenchymal lung disease with a requirement for supplemental oxygen support (for ≥3 consecutive days) at PMA 36 weeks to maintain arterial oxygen saturation in the range of 90-95%.
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)
Pulmonary function testing
Normal/Abnormal. Pulmonary function testing includes the following parameters: Breathing Frequency (BF), Inspiratory Time (TI)/ Expiratory Time Ratio (TE), Tidal Volume (VT), Time to Peak Tidal Expiratory Flow (TPTEF), Volume to Peak Tidal Expiratory Flow (VPTEF), etc. The determination of abnormal lung function in infants is primarily relies on the analysis of TPTEF/TE and VPTEF/VE ratios, the shape of the TBFV (Tidal Breathing Flow-Volume) loop, and the integration of clinical presentation.
Sponsors and contacts
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