International Peace Maternity and Child Health Hospital
Shanghai, Shanghai Municipality, China
Location status: Recruiting
NCT Number: NCT06925360
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.
Interested in participating?
Request InfoUp to 10 week
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, China
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 36 weeks of postmenstrual age
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: until first discharge home or 36 weeks PMA
Defined as cumulative days on assisted ventilation, support with oxygen, or both
Time frame: until first discharge home or 36 weeks PMA
Complications of preterm birth include retinopathy of prematurity, intraventricular hemorrhage, necrotizing enterocolitis, and septicemia et.al.
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years.
Neurodevelopmental testing (e.g., Denver Developmental Screening Test)
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
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
Vision screening with Spot Vision Screener
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
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 and 1 year
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, 1 year, and 2 years
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years
Contact information is provided by the study sponsor or research team.
Fu Xuemei
CONTACT
Li Dan
CONTACT
International Peace Maternity and Child Health Hospital
Other
The Efficacy of Intravenous Immunoglobulin for the Treatment of Bronchopulmonary Dysplasia
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