Bronchopulmonary Dysplasia Clinical Trials

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The Short-term and Long-term Effects of IVIG for Bronchopulmonary Dysplasia in Preterm Infant Born at 28 Weeks and Below

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 2 months
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
International Peace Maternity and Child Health Hospital
RECRUITING
Shanghai
Contact Information
Primary
Fu Xuemei
fxmzj2004@163.com
+86 18017313931
Backup
Li Dan
lidan910327@126.com
+86 18814100771
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2029-09
Participants
Target number of participants: 29
Treatments
Experimental: IVIG
Drug: intravenous immunoglobulin~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.
Sponsors
Leads: International Peace Maternity and Child Health Hospital

This content was sourced from clinicaltrials.gov