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

NCT03855202 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2019-02-26

No results posted yet for this study

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

Conditions

  • Neonates Premature
  • Ventilator Support

Interventions

BIOLOGICAL

CBMNC

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

BIOLOGICAL

PS

PS,dose is 70mg/kg

OTHER

Placeo

0.9% sodium chloride installation after 24 hours

Sponsors & Collaborators

  • yangjie

    lead OTHER

Principal Investigators

  • Jie Yang, PHD · Guangdong Women and Children Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-24
Primary Completion
2019-08-01
Completion
2020-08-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03855202 on ClinicalTrials.gov