Status:
UNKNOWN
Effect of Autologous Cord Blood Mononuclear Cells for Prevention of Bronchopulmonary Dysplasia or Death in Extremely Preterm Neonates
Lead Sponsor:
Guangdong Women and Children Hospital
Collaborating Sponsors:
Foshan Fuxing Chancheng Central Hospital
Foshan Women's and Children's Hospital
Conditions:
BPD
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE3
Brief Summary
This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of autologous cord blood mononuclear cells infusion as a prevention therapy for BPD or death. The result...
Detailed Description
Study design and settings: This present study will be a randomized, placebo-controlled, double-blinded, multi-center trial to be conducted at 12 medical centers in tertiary hospitals with Neonatal In...
Eligibility Criteria
Inclusion
- Infants fulfilling all the following inclusion criteria will be enrolled in this trial: 1. born at study hospital; 2. singleton birth; 3. less than 28 weeks GA 4.Signed informed consent obtained; 5. had available umbilical cord blood (UCB).
Exclusion
- Those infants are excluded if they were 1. with severe congenital abnormalities; 2.with maternal clinical chorioamnionitis 3. the mother was positive for hepatitis B (HBsAg and/or HBeAg) or C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) or IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.
Key Trial Info
Start Date :
June 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04440670
Start Date
June 20 2020
End Date
December 31 2023
Last Update
November 1 2023
Active Locations (2)
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1
Ren Xuejun
Dongguan, Guangdong, China
2
Jie Yang
Guangzhou, Guangdong, China, 511442