The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Neonates Premature
- Sponsor
- yangjie
- Enrollment
- 320
- Primary Endpoint
- number of patients who died
- Last Updated
- 7 years ago
Overview
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
Investigators
yangjie
Director of Dept of Neonatology
Guangdong Women and Children Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
number of patients who died
Time Frame: up to 21 days after birth
mority rate
Secondary Outcomes
- number of patients with neurodevelopmental disorder assessed by Bayley Score(up to 1 month, 3 month, 6 months and 1 year)