Jie Yang
Guangzhou, Guangdong, 511442, China
NCT Number: NCT04311476
To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
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Notify Me28 week–32 week
All sexes
Interventional
Phase 2
Guangzhou, Guangdong, 511442, China
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
Other names: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
0.9% Sodiun Chloride in control group
Time frame: at 36 weeks of postmenstrual age or discharge home, whichever came first
bronchopulmonary dysplasia incidence
Time frame: at 36 weeks of postmenstrual age
mortaliity rate
yangjie
Other
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