The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms (BPD)
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ClinicalTrials.gov Identifier: NCT03855202 |
Recruitment Status : Unknown
Verified February 2019 by yangjie, Guangdong Women and Children Hospital.
Recruitment status was: Not yet recruiting
First Posted : February 26, 2019
Last Update Posted : February 26, 2019
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Condition or disease | Intervention/treatment | Phase |
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Neonates Premature Ventilator Support | Biological: CBMNC Biological: PS+CBMNC Biological: PS Other: Placeo | Phase 1 |
This is a Phase 1 clinical trial that constitues one time points cohor and three group,each group with 80 participants,which receive intratracheal PS and mononuclaer cells,receive intratracheal PS,receive intratracheal mononuclaer cells.
- Eligibility Criteria:Preterm(gestational age more than 28weeks and less than 37weeks)
- Exlusion criteria: Preterm infants with major congenital malformations,chromosomal anomalies,inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
- Demographic Data and Baseline characteristics of the study groups were collected:
Gestational age(weeks) birth weight(g) gender Cesarean section delivery antenatal steroids prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes Thrombocytopenia before intervention CRP befor intervention(mg/l) TNF-αbefore intervention(pg/ml) 4.Autologous cord blood mononuclear cells doses is 25million cells/kg 5.the following are monitored at 3、7、14、21 days after birth: mortality, incidence of bronchopulmonary dysplasia 5.Long-term follow up:in 1m,3m,6m,1y:neurodevelopment,asthma,anemia and physic growth
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 320 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms |
Estimated Study Start Date : | February 24, 2019 |
Estimated Primary Completion Date : | August 1, 2019 |
Estimated Study Completion Date : | August 20, 2020 |

Arm | Intervention/treatment |
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Experimental: infusion froup 1
autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg
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Biological: CBMNC
autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg |
Experimental: infusion group 2
autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg
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Biological: PS+CBMNC
autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg |
Experimental: infusion group 3
PS,dose is 70mg/kg
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Biological: PS
PS,dose is 70mg/kg |
Placebo Comparator: Placebol
0.9% sodium chloride installation after 24 hours
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Other: Placeo
0.9% sodium chloride installation after 24 hours |
- number of patients who died [ Time Frame: up to 21 days after birth ]mority rate
- number of patients with neurodevelopmental disorder assessed by Bayley Score [ Time Frame: up to 1 month, 3 month, 6 months and 1 year ]Long term follow up:in 1 month, 3months,6 months,and 1 years:

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Ages Eligible for Study: | 28 Weeks to 36 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
twenty-eight weeks to thirty-seven weeks
Exclusion Criteria:
Pretem infants with major congenital malformations,chromosomal anomalies,inborn errors of metabolism and clinical or laboratory evidence of a congenital infection

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): NCT03855202
Contact: Zhuxiao Ren, MD | +8613538984634 | renzhx1990@163.com |
Principal Investigator: | Jie Yang, PHD | Guangdong Women and Children Hospital |
Responsible Party: | yangjie, Director of Dept of Neonatology, Guangdong Women and Children Hospital |
ClinicalTrials.gov Identifier: | NCT03855202 |
Other Study ID Numbers: |
Guangdong W C H |
First Posted: | February 26, 2019 Key Record Dates |
Last Update Posted: | February 26, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
PS cord blood mononuclaer Cells preterm |
Bronchopulmonary Dysplasia Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Ventilator-Induced Lung Injury |
Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases |