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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03855202
Acronym
BPD
Enrollment
320
Registered
2019-02-26
Start date
2019-02-24
Completion date
2020-08-20
Last updated
2019-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonates Premature, Ventilator Support

Keywords

PS, cord blood mononuclaer Cells, preterm

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

Interventions

BIOLOGICALCBMNC

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

BIOLOGICALPS+CBMNC

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

BIOLOGICALPS

PS,dose is 70mg/kg

OTHERPlaceo

0.9% sodium chloride installation after 24 hours

Sponsors

yangjie
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 36 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
number of patients who diedup to 21 days after birthmority rate

Secondary

MeasureTime frameDescription
number of patients with neurodevelopmental disorder assessed by Bayley Scoreup to 1 month, 3 month, 6 months and 1 yearLong term follow up:in 1 month, 3months,6 months,and 1 years:

Contacts

Primary ContactZhuxiao Ren, MD
renzhx1990@163.com+8613538984634

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026