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IVIG Trial for the Treatment of Bronchopulmonary Dysplasia

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Primary endpoint(s) modified
    • Eligibility criteria expanded, about 8 words
    v6
  2. Minor Secondary endpoints: 14 to 11v5
  3. Minor Enrollment target: 14 to 20
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 5 to 14
    v4
  4. Notable Enrollment target: 20 to 14
    • Eligibility criteria revised
    v3
  5. Notable Enrollment target: 10 to 20
    • Start date changed from estimate of Apr 2025 to Apr 12, 2025
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
It is intended to examine the efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms. 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 Details
NCT Number NCT06925360
Lead Sponsor International Peace Maternity and Child Health Hospital
Conditions
(from sponsor)
Bronchopulmonary Dysplasia
Related terms Bronchopulmonary Dysplasia
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov