Effects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below (NCT07561125) | Clinical Trial Compass
RecruitingPhase 2
Effects of IVIG for BPD in Preterm Infant Born at 28 Weeks and Below
China29 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range1 Day – 10 Weeks
SexALL
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Inclusion Criteria:
* Gestational age ≤ 28 weeks + 6 days
* Admission within 24 hours after birth.
* Infants show a suspicion of BPD, the diagnosis is suspected based on the following clinical manifestations and chest X-ray findings.
Clinical manifestations: Respiratory symptoms such as tachypnea (rapid breathing) and cyanosis, requiring respiratory support (including invasive, non-invasive, or oxygen therapy) to maintain oxygen saturation.
Chest X-ray: Findings include increased bilateral lung markings or ground-glass opacities, and diffuse increased density in both lungs. Other possible causes such as infection or heart disease should be 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
What they're measuring
1
rate of BPD and severity classification at postmenstrual age (PMA) 36 weeks
Timeframe: 36 weeks of postmenstrual age
Trial details
NCT IDNCT07561125
SponsorInternational Peace Maternity and Child Health Hospital