Safety Issues Clinical Trial
Official title:
Autologous Cord Blood Cells for Prevention of BPD in Preterm
Verified date | May 2020 |
Source | Guangdong Women and Children Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
Status | Completed |
Enrollment | 62 |
Est. completion date | January 1, 2020 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 28 Weeks to 32 Weeks |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | Jie Yang | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
yangjie |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of patients without bronchopulmonary dysplasia | bronchopulmonary dysplasia incidence | at 36 weeks of postmenstrual age or discharge home, whichever came first | |
Secondary | number of patients who died, severe bronchopulmonary dysplasia | mortaliity rate | at 36 weeks of postmenstrual age |
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