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

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

Study Overview

• Status: Unknown
• Conditions: Neonates Premature; Ventilator Support
• Intervention / Treatment: Biological: CBMNC; Biological: PS+CBMNC; Biological: PS; Other: Placeo

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

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: zhuxiao Ren, MD; Phone Number: +8613538984634; Email: renzhx1990@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: infusion froup 1; autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg	Biological: CBMNC; autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg
Experimental: infusion group 2; autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/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
Experimental: infusion group 3; PS,dose is 70mg/kg	Biological: PS; PS,dose is 70mg/kg
Placebo Comparator: Placebol; 0.9% sodium chloride installation after 24 hours	Other: Placeo; 0.9% sodium chloride installation after 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients who died	mority rate	up to 21 days after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with neurodevelopmental disorder assessed by Bayley Score	Long term follow up:in 1 month, 3months,6 months,and 1 years:	up to 1 month, 3 month, 6 months and 1 year

Collaborators and Investigators

• Sponsor: yangjie
• Investigators: Principal Investigator: Jie Yang, PHD, Guangdong Women and Children Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 24, 2019
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 20, 2020

Study Registration Dates

• First Submitted: February 24, 2019
• First Submitted That Met QC Criteria: February 24, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 24, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: preterm; PS; cord blood mononuclaer Cells
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Premature Birth; Bronchopulmonary Dysplasia
• Other Study ID Numbers: Guangdong W C H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No