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

Neonates Premature Clinical Trial

— BPD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03855202
• Other study ID #: Guangdong W C H
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 24, 2019
• Est. completion date: August 20, 2020

Study information

• Verified date: February 2019
• Source: Guangdong Women and Children Hospital
• Contact: Zhuxiao Ren, MD
• Phone: +8613538984634
• Email: renzhx1990[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: August 20, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 36 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Neonates Premature
• Premature Birth
• Ventilator Support

Intervention

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

Other:
• Placeo
0.9% sodium chloride installation after 24 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
yangjie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients who died	mority rate	up to 21 days after birth
Secondary	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