Neonates Premature, Ventilator Support
Conditions
Keywords
PS, cord blood mononuclaer Cells, preterm
Brief summary
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
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. 1. Eligibility Criteria:Preterm(gestational age more than 28weeks and less than 37weeks) 2. Exlusion criteria: Preterm infants with major congenital malformations,chromosomal anomalies,inborn errors of metabolism and clinical or laboratory evidence of a congenital infection 3. 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
Interventions
autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg
autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg
PS,dose is 70mg/kg
0.9% sodium chloride installation after 24 hours
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients who died | up to 21 days after birth | mority rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with neurodevelopmental disorder assessed by Bayley Score | up to 1 month, 3 month, 6 months and 1 year | Long term follow up:in 1 month, 3months,6 months,and 1 years: |