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

Phase 1

• Conditions: Neonates Premature; Ventilator Support
• Interventions: Biological: PS+CBMNC; Other: Placeo; Biological: CBMNC; Biological: PS

• Registration Number: NCT03855202
• Lead Sponsor: yangjie

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

Study Timeline

• Status Verified: 2019-02
• Study Start: 2019-02-24
• Study First Submitted: 2019-02-24
• Study First Submitted QC: 2019-02-24
• Last Update Submitted: 2019-02-24
• Study First Posted: 2019-02-26
• Last Update Posted: 2019-02-26
• Primary Completion: 2019-08-01
• Study Completion: 2020-08-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
infusion group 2	PS+CBMNC	autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg
Placebol	Placeo	0.9% sodium chloride installation after 24 hours
infusion froup 1	CBMNC	autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg
infusion group 3	PS	PS,dose is 70mg/kg

Primary Outcome Measures

Name	Time	Method
number of patients who died	up to 21 days after birth	mority rate

Secondary Outcome Measures

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