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

yangjie

Status and phase: Unknown; Phase 1

Conditions: Ventilator Support; Neonates Premature

Treatments: Other: Placeo; Biological: PS+CBMNC; Biological: PS; Biological: CBMNC

Study type: Interventional

Funder types: Other

Identifiers

NCT03855202

Guangdong W C H

Details and patient eligibility

About

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

Full 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.

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

Enrollment: 320 estimated patients

Sex: All

Ages: 28 to 36 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 4 patient groups, including a placebo group

infusion froup 1

Experimental group

Description:

autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg

Treatment:

Biological: CBMNC

infusion group 2

Experimental group

Description:

autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg

Treatment:

Biological: PS+CBMNC

infusion group 3

Experimental group

Description:

PS,dose is 70mg/kg

Treatment:

Biological: PS

Placebol

Placebo Comparator group

Description:

0.9% sodium chloride installation after 24 hours

Treatment:

Other: Placeo