Status:
COMPLETED
Autologous Cord Blood Cells for Prevention of BPD in Preterm
Lead Sponsor:
yangjie
Conditions:
Safety Issues
BPD - Bronchopulmonary Dysplasia
Eligibility:
All Genders
28-32 years
Phase:
PHASE2
Brief Summary
To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
Detailed Description
We did a randomized, double-blind, placebo-controlled trial to assess effect of one intravenous dose of cord blood MNCs compared with placebo in reducing incidence of BPD in very preterm neonates.We e...
Eligibility Criteria
Inclusion
- born in the study hospital;
- singleton birth;
- less than 32 weeks GA
- Without congenital malformations or known chromosomal aberrations;
- Without clinical chorioamnionitis;
- the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus;
- consents were obtained from their parents or guardians;
- the umbilical cord blood cells after processing were available.
Exclusion
- birth-weight was less than the third percentile for gestational age according to Fenton curve,
- if they had severe perinatal asphyxia (defined as an Apgarscore of 0-3 for more than 5 minutes, a cord blood pH of less than 7.00, or both) and were expected to die shortly after birth.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04311476
Start Date
July 1 2018
End Date
January 1 2020
Last Update
June 2 2020
Active Locations (1)
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1
Jie Yang
Guangzhou, Guangdong, China, 511442