Effect of Autologous Cord Blood Mononuclear Cells for Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Neonates: a Placebo-controlled Randomized Multicenter Trial
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|ClinicalTrials.gov Identifier: NCT04440670|
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : June 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|BPD||Biological: autologous cord blood mononuclear cells Biological: normal saline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||In this prospective, randomized controlled double-blind multi-center clinical trial, 200 preterm neonates less than 28 weeks are randomly assigned to receive intravenous autologous cord blood mononuclear cells infusion (5×107cells/kg) or placebo ( normal saline) within 24 hours after birth in a 1:1 ratio using a central randomization system.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||A hospital ethics committee reviewed the study data during the trials. None of them were involved in the study or aware of the treatment-group assignments of the infants. Only nurses and physicians staff conducted the infusion were aware of the treatment assignment, and these individuals had no contact with the staff who collected and analyzed the patients data. The parents are not aware of the assignment. This study is double-blinded.|
|Official Title:||Effect of Autologous Cord Blood Mononuclear Cells for Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Neonates: a Placebo-controlled Randomized Multicenter Trial|
|Estimated Study Start Date :||June 20, 2020|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
Experimental: ACBMNC infusion group
Those assigned to the ACBMNC group will receive intravenous autologous cord blood mononuclear cells infusion within 24 h after birth. Cell dose for all patients was targeted at 5×107 cells per kilogram.
Biological: autologous cord blood mononuclear cells
preterm neonates less than 28 weeks are assigned to receive intravenous autologous cord blood mononuclear cells infusion (5×107cells/kg) within 24 hours after birth
Placebo Comparator: control group
Those in control group will receive an infusion of a placebo solution which is normal saline with the same volume.
Biological: normal saline
preterm neonates less than 28 weeks are assigned to receive normal saline within 24 hours after birth
- frequency of bronchopulmonary dysplasia [ Time Frame: 36 weeks of postmenstrual age or discharge home whichever comes first. ]The frequency of bronchopulmonary dysplasia at 36 weeks of postmenstrual age or discharge home whichever comes first.
- mortality [ Time Frame: 36 weeks of postmenstrual age or the discharge ]
The mortality rate.
- Incidence of other preterm complications including intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), respiratory distress syndrome (RDS), ventilation-associated pneumonia (VAP), late onset sepsis (LOS) and anemia .
- Duration of hospitalization.
- Duration of mechanical ventilation and oxygen therapy
- The frequency of re-intubation.
- The time (days) return to BW.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440670
|Contact: zhuxiao Ren, MDemail@example.com|
|Study Chair:||Jie Yang||Guangdong Women and Children Hospital|