NCT03855202

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: yangjie · Academic / Other
• Sex: All
• Age: 28 Weeks – 36 Weeks
• Healthy volunteers: Not accepted

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

Conditions

• Neonates Premature
• Ventilator Support

Interventions

Type	Name	Description
BIOLOGICAL	CBMNC	autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg
BIOLOGICAL	PS+CBMNC	autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg
BIOLOGICAL	PS	PS,dose is 70mg/kg
OTHER	Placeo	0.9% sodium chloride installation after 24 hours

Timeline

• Start date: 2019-02-24
• Primary completion: 2019-08-01
• Completion: 2020-08-20
• First posted: 2019-02-26
• Last updated: 2019-02-26