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Bronchopulmonary dysplasia mainly occurs in premature infants, which is the main cause of premature infant death.If children with BPD can survive, they are also prone to complications of long-term respiratory diseases such as asthma,that affect the quality of life of BPD children. However, there is no effective treatment method for BPD. So,the investigator would like to investigate the effect of Intratracheal PS and mononuclaer cells in pretems
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| infusion froup 1 | Experimental | autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg |
|
| infusion group 2 | Experimental | 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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| infusion group 3 | Experimental | PS,dose is 70mg/kg |
|
| Placebol | Placebo Comparator | 0.9% sodium chloride installation after 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBMNC | Biological | autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of patients who died | mority rate | up to 21 days after birth |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with neurodevelopmental disorder assessed by Bayley Score | Long term follow up:in 1 month, 3months,6 months,and 1 years: | up to 1 month, 3 month, 6 months and 1 year |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhuxiao Ren, MD | Contact | +8613538984634 | renzhx1990@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Yang, PHD | Guangdong Women and Children Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| PS+CBMNC | Biological | autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg |
|
| PS | Biological | PS,dose is 70mg/kg |
|
| Placeo | Other | 0.9% sodium chloride installation after 24 hours |
|
| D000091642 | Urogenital Diseases |