It is intended to examine the efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms. 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
20
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, Shanghai Municipality, China
RECRUITINGDiagnosis 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)
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.
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Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Vision screening
Vision screening with Spot Vision Screener
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Bone density measurement
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Blood routine tests
Including white blood cell count, differential white blood cell count (such as neutrophils, lymphocytes, etc.), red blood cell count, hemoglobin concentration, platelet count, etc
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Rehabilitation evaluation
e.g., Alberta Infant Motor Scale Assessment Report, 0-58 (min- max value), higher scores mean a better outcome.
Time frame: Corrected age/ chronological age of 6 months and 1 year
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