The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms

Conditions
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Neonates Premature, Ventilator Support

Intervention / Treatment
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* Biological: CBMNC
* Biological: PS+CBMNC
* Biological: PS
* Other: Placeo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: infusion froup 1<br>autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg | Biological: CBMNC<br>* autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg<br>|
| Experimental: infusion group 2<br>autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg | Biological: PS+CBMNC<br>* autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg<br>|
| Experimental: infusion group 3<br>PS,dose is 70mg/kg | Biological: PS<br>* PS,dose is 70mg/kg<br>|
| Placebo Comparator: Placebol<br>0.9% sodium chloride installation after 24 hours | Other: Placeo<br>* 0.9% sodium chloride installation after 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who died | mority rate | up to 21 days after birth | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PS, cord blood mononuclaer Cells, preterm