IVIG for bronchopulmonary dysplasia in infants born at 28 weeks or earlier

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, single-center interventional trial testing a five-day IVIG regimen in extremely preterm infants with suspected early bronchopulmonary dysplasia. Participants are infants born at ≤28 weeks + 6 days who are admitted within 24 hours and have respiratory symptoms plus chest X-ray findings consistent with early BPD. The dosing schedule is 1 g/kg/day as a continuous infusion for the first two days followed by 0.5 g/kg/day for the next three days (total 3.5 g/kg), with the course repeatable if clinically required. The study will monitor short-term and long-term safety and measures of respiratory support and lung outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• International Peace Maternity and Child Health Hospital
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Fu Xuemei — International Peace Maternity and Child Health Hospital
• Study coordinator: Fu Xuemei
• Email: fxmzj2004@163.com
• Phone: +86 18017313931

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing two IV lipid infusions for very preterm or very low birth weight infants

  This study will try two types of intravenous lipid emulsions (mixed-oil vs soybean-oil) in extremely preterm or very low birth weight infants to see which better prevents bronchopulmonary dysplasia and supports growth and brain development.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.