Recruiting NCT06925360
IVIG Trial for the Treatment of Bronchopulmonary Dysplasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intravenous immunoglobulin.
- Who it may be relevant to
- Registry conditions: Bronchopulmonary Dysplasia. Basic parameters: up to 10 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficacy of Intravenous Immunoglobulin for the Treatment of Bronchopulmonary Dysplasia
Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- Diagnosis of bronchopulmonary dysplasia and severity of the condition at 36 weeks of PMA [Time frame: 36 weeks of postmenstrual age]
Secondary outcome measures (11)
- duration of respiratory support [Time frame: until first discharge home or 36 weeks PMA]
- Preterm birth complications [Time frame: until first discharge home or 36 weeks PMA]
- Neurodevelopmental assessment [Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years.]
- Pulmonary function testing [Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years]
- Vision screening [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 [Time frame: Corrected age/ chronological age of 6 months, 1 year, and 2 years]
- Rehabilitation evaluation [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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- International Peace Maternity and Child Health Hospital — Shanghai
Identifiers
NCT: NCT06925360 · GKLW-A-2024-114-01