Neonates Premature Clinical Trial
Official title:
The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms
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.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03019692 -
Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage
|
N/A |