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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
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.
International Peace Maternity and Child Health Hospital
Shanghai, China
RECRUITINGrate 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%.
Time frame: 36 weeks of postmenstrual age
duration of respiratory support
Defined as cumulative days on assisted ventilation, support with oxygen, or both
Time frame: until first discharge home or 36 weeks PMA
Preterm birth complications
Complications of preterm birth include retinopathy of prematurity, intraventricular hemorrhage, necrotizing enterocolitis, and septicemia et.al.
Time frame: until first discharge home or 36 weeks PMA
Neurodevelopmental assessment
Neurodevelopmental testing (e.g., Denver Developmental Screening Test)
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
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.
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
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Weight
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Length
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Head circumference
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years