The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms
BPD
1 other identifier
interventional
320
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2019
CompletedStudy Start
First participant enrolled
February 24, 2019
CompletedFirst Posted
Study publicly available on registry
February 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2020
CompletedFebruary 26, 2019
February 1, 2019
5 months
February 24, 2019
February 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of patients who died
mority rate
up to 21 days after birth
Secondary Outcomes (1)
number of patients with neurodevelopmental disorder assessed by Bayley Score
up to 1 month, 3 month, 6 months and 1 year
Study Arms (4)
infusion froup 1
EXPERIMENTALautologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg
infusion group 2
EXPERIMENTALautologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg
infusion group 3
EXPERIMENTALPS,dose is 70mg/kg
Placebol
PLACEBO COMPARATOR0.9% sodium chloride installation after 24 hours
Interventions
Eligibility Criteria
You may qualify if:
- twenty-eight weeks to thirty-seven weeks
You may not qualify if:
- Pretem infants with major congenital malformations,chromosomal anomalies,inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- yangjielead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Yang, PHD
Guangdong Women and Children Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Dept of Neonatology
Study Record Dates
First Submitted
February 24, 2019
First Posted
February 26, 2019
Study Start
February 24, 2019
Primary Completion
August 1, 2019
Study Completion
August 20, 2020
Last Updated
February 26, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share