Using IVIG to treat bronchopulmonary dysplasia in premature infants

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 clinical trial aims to evaluate the efficacy and safety of intravenous immunoglobulin (IVIG) in treating bronchopulmonary dysplasia (BPD) in preterm infants. Participants will receive a continuous infusion of IVIG at a dosage of 1 g/kg/day for the first two days, followed by 0.5 g/kg/day for the next three days, with the possibility of repeating the treatment if necessary. The study focuses on infants who show clinical symptoms and chest X-ray results indicative of BPD shortly after birth. The goal is to determine whether IVIG can improve respiratory outcomes in this vulnerable population.

Why it matters

Who can join: the full rules

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

Where it's running

• International Peace Maternity and Child Health Hospital
  Shanghai, Shanghai Municipality, 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

Similar studies

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

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  This study tests whether lung ultrasound scores in the first two weeks of life can predict which extremely preterm babies will develop bronchopulmonary dysplasia.

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

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  Recruiting Phase 2 International Peace Maternity and Child Health Hospital · Shanghai · NCT07561125

• High-energy DHA/ARA-enriched human milk in the first 2 weeks to lower lung problems in extremely preterm babies

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  Recruiting Phase 1/2 University of Alabama at Birmingham · Birmingham, Alabama · NCT07307612

• Reduced versus higher daily fluids to prevent bronchopulmonary dysplasia in very preterm babies

  This tests whether giving smaller daily fluid volumes from day 8 of life (about 135 mL/kg/day) instead of larger volumes (about 165 mL/kg/day) lowers the chance of developing BPD or dying before 36 weeks in babies born before 30 weeks.

  Recruiting at 9 sites University Children's Hospital Basel · Aarau and 8 other locations · NCT06954142

• 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.

  Recruiting Phase 2 The University of Texas Health Science Center, Houston · Houston, Texas · NCT06915441

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.