Effects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below
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.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
1 Day – 10 Weeks
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
29 (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 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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Gestational age ≤ 28 weeks + 6 days
* Admission within 24 hours after birth.
* Clinical presentation and chest X radiograph changes of BPD
Clinical presentation: The respiratory symptoms and signs developed within several days or weeks after birth, such as shortness of breath…
Inclusion Criteria:
* Gestational age ≤ 28 weeks + 6 days
* Admission within 24 hours after birth.
* Clinical presentation and chest X radiograph changes of BPD
Clinical presentation: The respiratory symptoms and signs developed within several days or weeks after birth, such as shortness of breath, cyanosis or pulmonary rales, intermittent hypoxic attacks, and chronic oxygen dependence that requires invasive or non-invasive respiratory supports or oxygen inhalation to maintain blood oxygen saturation.
Chest X radiograph changes: The bilateral increased bronchovascular markings or ground-glass opacity and bilateral diffuse increased density, after the possible cause of other diseases such as infection and heart disease have been ruled out.
• 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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