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
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) 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.
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Weight
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
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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
Tidal Breathing Flow-Volume Curve Parameters
Measurement of tidal breathing flow-volume curve (TBFV)-derived indices, with primary focus on TPTEF/TE (time to peak tidal expiratory flow to total expiratory time ratio) and VPTEF/VE (volume to peak tidal expiratory flow to total expiratory volume ratio)
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Composite Clinical Assessment of Pulmonary Function Status
Categorization of overall pulmonary function status as Normal or Abnormal. As validated normative percentile references for TBFV-derived parameters are unavailable for preterm infants, classification is not based on fixed numerical cutoffs. Instead, the final determination is made through integrative clinical judgment combining: (a) quantitative analysis of TBFV curve parameters (TPTEF/TE and VPTEF/VE), (b) qualitative assessment of TBFV curve morphology (e.g., shape of the flow-volume trajectory, presence of expiratory flow limitation or concavity), and (c) concurrent clinical presentation (e.g., signs of respiratory distress, wheezing, oxygen requirement). The final Normal/Abnormal classification is assigned by the attending clinician based on comprehensive evaluation of all three domains.
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years