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

Primary Purpose

Neonates Premature, Ventilator Support

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

CBMNC

PS+CBMNC

Placeo

About this trial

This is an interventional prevention trial for Neonates Premature focused on measuring PS, cord blood mononuclaer Cells, preterm

Eligibility Criteria

28 Weeks - 36 Weeks (Child)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

infusion froup 1

infusion group 2

infusion group 3

Placebol

Arm Description

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

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

PS,dose is 70mg/kg

0.9% sodium chloride installation after 24 hours

Outcomes

Primary Outcome Measures

number of patients who died

mority rate

Secondary Outcome Measures

number of patients with neurodevelopmental disorder assessed by Bayley Score

Long term follow up:in 1 month, 3months,6 months,and 1 years:

Full Information

NCT ID

NCT03855202

First Posted

February 24, 2019

Last Updated

February 24, 2019

Sponsor

yangjie

1. Study Identification

Unique Protocol Identification Number

NCT03855202

Brief Title

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

Acronym

BPD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 24, 2019 (Anticipated)

Primary Completion Date

August 1, 2019 (Anticipated)

Study Completion Date

August 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

yangjie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neonates Premature, Ventilator Support

Keywords

PS, cord blood mononuclaer Cells, preterm

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

infusion froup 1

Arm Type

Experimental

Arm Description

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

Arm Title

infusion group 2

Arm Type

Experimental

Arm Description

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

Arm Title

infusion group 3

Arm Type

Experimental

Arm Description

PS,dose is 70mg/kg

Arm Title

Placebol

Arm Type

Placebo Comparator

Arm Description

0.9% sodium chloride installation after 24 hours

Intervention Type

Biological

Intervention Name(s)

CBMNC

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

PS+CBMNC

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Intervention Description

PS,dose is 70mg/kg

Intervention Type

Other

Intervention Name(s)

Placeo

Intervention Description

0.9% sodium chloride installation after 24 hours

Primary Outcome Measure Information:

Title

number of patients who died

Description

mority rate

Time Frame

up to 21 days after birth

Secondary Outcome Measure Information:

Title

number of patients with neurodevelopmental disorder assessed by Bayley Score

Description

Long term follow up:in 1 month, 3months,6 months,and 1 years:

Time Frame

up to 1 month, 3 month, 6 months and 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

28 Weeks

Maximum Age & Unit of Time

36 Weeks

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhuxiao Ren, MD

Phone

+8613538984634

renzhx1990@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jie Yang, PHD

Organizational Affiliation

Guangdong Women and Children Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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