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

Y

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

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

Trial contacts and locations

0

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Central trial contact

Zhuxiao Ren, MD

Data sourced from clinicaltrials.gov

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