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

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ClinicalTrials.gov Identifier: NCT03855202
Recruitment Status : Not yet recruiting
First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
yangjie, Guangdong Women and Children Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Neonates Premature Ventilator Support Biological: CBMNC Biological: PS+CBMNC Biological: PS Other: Placeo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms
Estimated Study Start Date : February 24, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 20, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: infusion froup 1
autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg
 Biological: CBMNC
autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg
Experimental: infusion group 2
autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/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
Experimental: infusion group 3
PS,dose is 70mg/kg
 Biological: PS
PS,dose is 70mg/kg
Placebo Comparator: Placebol
0.9% sodium chloride installation after 24 hours
 Other: Placeo
0.9% sodium chloride installation after 24 hours


Outcome Measures
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Primary Outcome Measures :
  1. number of patients who died [ Time Frame: up to 21 days after birth ]
    mority rate


Secondary Outcome Measures :
  1. number of patients with neurodevelopmental disorder assessed by Bayley Score [ Time Frame: up to 1 month, 3 month, 6 months and 1 year ]
    Long term follow up:in 1 month, 3months,6 months,and 1 years:


Eligibility Criteria
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Ages Eligible for Study:   28 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855202


Contacts
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Contact: Zhuxiao Ren, MD +8613538984634 renzhx1990@163.com

Sponsors and Collaborators
yangjie
Investigators
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Principal Investigator: Jie Yang, PHD Guangdong Women and Children Hospital
More Information
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Responsible Party: yangjie, Director of Dept of Neonatology, Guangdong Women and Children Hospital
ClinicalTrials.gov Identifier: NCT03855202     History of Changes
Other Study ID Numbers: Guangdong W C H
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by yangjie, Guangdong Women and Children Hospital:
PS
cord blood mononuclaer Cells
preterm

Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Premature Birth
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
 Infant, Premature, Diseases
Infant, Newborn, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications