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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 0.9% sodium chloride infusion within 24 hours after birth |
|
| ACBMNC | Experimental | Autologous Umbilical Cord Blood Mononuclear Cells intravenously within 24 hours after birth,dose is 5×107cells/kg , |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy | Other | Evaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients without bronchopulmonary dysplasia | bronchopulmonary dysplasia incidence | at 36 weeks of postmenstrual age or discharge home, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients who died, severe bronchopulmonary dysplasia | mortaliity rate | at 36 weeks of postmenstrual age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Yang, PHD | Guangdong Women and Children Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jie Yang | Guangzhou | Guangdong | 511442 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 17, 2020 | |
| Unrelease | Jun 18, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2020 | Jun 18, 2020 |
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D066087 | Perinatal Death |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| 0.9% Sodiun Chloride | Drug | 0.9% Sodiun Chloride in control group |
|
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |