intravenous immunoglobulin: 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 summary
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.
Eligibility
Sex
ALL
Min age
—
Max age
10 Weeks
Healthy volunteers
Accepted
Inclusion Criteria:
* Gestational age between 25 weeks and 29 weeks + 6 days
* Admission within 24 hours after birth.
* Clinical symptoms and chest X-ray results show a highly suspicion of BPD （Clinical symptoms and chest X-ray changes of BPD）.Clinical symptoms develop in several days or weeks after birth, including respiratory symptoms and signs such as shortness of breath, cyanosis or pulmonary rales, intermittent hypoxic attacks, and chronic oxygen dependence (increased oxygen concentration and assisted ventilation) .One of the following signs present in chest X-ray: lung texture thickening or ground glass opacity in early stage, diffuse lung texture blurred, lung hyperinflation, shadow of linear density increased, and shadow of triangular density increased under the pleura.
* A normal full-term newborn without a history of severe lung diseases, birth asphyxia, hypoxic-ischemic encephalopathy or other conditions that may affect the development of the respiratory, nervous and other systems.
Exclusion Criteria:
* 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
* With severe lung infections
* Other circumstances that the investigator determines are not suitable for participation in this study
Primary outcome measure(s)
Diagnosis of bronchopulmonary dysplasia and severity of the condition at 36 weeks of PMA — 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)
Trial sites (1)
Facility
City
Region
Status
International Peace Maternity and Child Health Hospital
Shanghai
Shanghai Municipality
Recruiting
More International Peace Maternity and Child Health Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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