A Phase 2 interventional study of Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy and 0.9% Sodiun Chloride in Safety Issues, BPD - Bronchopulmonary Dysplasia and Neonatal Death, sponsored by yangjie. Completed at 1 site in China. Open to participants aged 28 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2020-06-02.
Sponsored by yangjie · Phase 2, Interventional, and Prevention
To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
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 enrolled preterm neonates less than 32 weeks of GA at neonatal intensive care units (NICUs) in Guangdong Women and Children Hospital within the first 24 postnatal hours. Patients were randomly assigned by 1:1 to receive either (5×107cells/kg ACBMNC or normal saline intravenously within 24 hours after birth according to a computer-generated schedule. The primary endpoint was efficacy at 36 GA or discharge home and all analyses were done by intention to prevent.MNCs viability was also tested before transfusion
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This study's enrollment of 62 is below the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.
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Exclusion Criteria:
0.9% sodium chloride infusion within 24 hours after birth
Drug: 0.9% Sodiun Chloride
Autologous Umbilical Cord Blood Mononuclear Cells intravenously within 24 hours after birth,dose is 5×107cells/kg ,
Other: Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy
Evaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
Also known as: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
0.9% Sodiun Chloride in control group
number of patients without bronchopulmonary dysplasia
bronchopulmonary dysplasia incidence
Time frame: at 36 weeks of postmenstrual age or discharge home, whichever came first
number of patients who died， severe bronchopulmonary dysplasia
mortaliity rate
Time frame: at 36 weeks of postmenstrual age
Plan to share: No
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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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