IVIG Trial for the Treatment of Bronchopulmonary Dysplasia
Recruiting
Phase 2Interventional Study
Bronchopulmonary Dysplasia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
Up to 10 Weeks
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
International Peace Maternity and Child Health Hospital · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 afte…
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
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