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

NCT ID: NCT03855202

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-24
• Study Completion Date: 2020-08-20

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

Conditions

Neonates Premature; Ventilator Support

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

infusion froup 1

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

Group Type: EXPERIMENTAL

CBMNC

Intervention Type: BIOLOGICAL

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

infusion group 2

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

Group Type: EXPERIMENTAL

PS+CBMNC

Intervention Type: BIOLOGICAL

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

infusion group 3

PS,dose is 70mg/kg

Group Type: EXPERIMENTAL

PS

Intervention Type: BIOLOGICAL

PS,dose is 70mg/kg

Placebol

0.9% sodium chloride installation after 24 hours

Group Type: PLACEBO_COMPARATOR

Placeo

Intervention Type: OTHER

0.9% sodium chloride installation after 24 hours

Interventions

CBMNC

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

Intervention Type: BIOLOGICAL

PS+CBMNC

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

Intervention Type: BIOLOGICAL

PS

PS,dose is 70mg/kg

Intervention Type: BIOLOGICAL

Placeo

0.9% sodium chloride installation after 24 hours

Intervention Type: OTHER

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

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

yangjie

OTHER

Sponsor Role: lead

Responsible Party

yangjie

Director of Dept of Neonatology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jie Yang, PHD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Women and Children Hospital

Central Contacts

Zhuxiao Ren, MD

Role: CONTACT

renzhx1990@163.com

+8613538984634

Other Identifiers

Guangdong W C H

Identifier Type: -

Identifier Source: org_study_id