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Prevention of Preterm Infection by Autologous Umbilical Cord Blood Mononuclear Cells Therapy

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ClinicalTrials.gov Identifier: NCT02999373
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
yangjie, Guangdong Women and Children Hospital

Tracking Information
First Submitted Date  ICMJE December 3, 2016
First Posted Date  ICMJE December 21, 2016
Last Update Posted Date April 10, 2017
Estimated Study Start Date  ICMJE April 7, 2017
Estimated Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2016)
number of patients infected of bacteria measured by blood culture [ Time Frame: up tp 21dyas after birth ]
infectious rate
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02999373 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
  • number of patients with neurodevelopmental disorder assessed by Bayley Score [ Time Frame: up to 1 month, 3 months ,6 months and 1 year ]
    Long term follow up: in 1month, 3months, 6months,and 1y: neurodevelopment assessed by Bayley Score
  • number of patients died before discharge from hospital [ Time Frame: up to 28days after birth ]
    mortality before discharge from hospital
Original Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2016)
  • number of patients with neurodevelopmental disorder assessed by Bayley Score [ Time Frame: up to 1 year ]
    Long term follow up: in 1m, 3m, 6m,1y: neurodevelopment assessed by Bayley Score
  • number of patients died before discharge from hospital [ Time Frame: up to 28days after birth ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Preterm Infection by Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Official Title  ICMJE Prevention of Preterm Infection by Autologous Umbilical Cord Blood Mononuclear Cells(CBMNC) Therapy
Brief Summary About 37% of neonatal mortality are caused by infection worldwidely . Excessive application of broad-spectrum antibiotics increased drug-resistance, however does not decrease morbility and mortality of neonates. Based on the investigator' early in vitro experiments which found cord blood mononuclear cells can inhibit bacterial growth and reduce of drug-resistance, along with other studies conducted recently from other groups who have reported the successful use of umbilical cord blood mononuclear cells in animal sepsis.The investigator would like to investigate the effects of umbilical cord blood mononuclear cells on prevention effect of preterm infection.
Detailed Description

This is a Phase 1 clinical trial that constitutes two time points cohorts with 80 participants per cohort who will receive intravenous doses of Autologous Umbilical Cord Blood Mononuclear Cells --25 million cells/kg,6 hours or 48 hours after birth. And the placebo will be 0.9% sodium chloride.The investigator will proceed the groups during the same period.

  1. Eligibility Criteria:Preterm (gestational age more than 28weeks and less than 37weeks )
  2. Exclusion 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 Studied 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 before intervention (mg/L) TNF-α(tumor necrosis factor α ) before intervention (pg/mL)

  4. Assessment of clinical condition in the course by measurement of arterial blood pressure, heart and respiratory rates and skin temperature was recorded continuously
  5. Autologous cord blood mononuclear cells doses is 25 million cells/kg ,the infusion speed is 4ml/kg/h, 8-12h,and with same volume of 0.9% sodium chloride as placebo.

    When the clinical symptoms suggests infection, blood cultures were performed before administration of antibiotics, and antibiotics were adjusted according to the susceptibility of the isolated bacteria.

  6. The following are monitored at 3、7、14、21days after birth :

    panels of cytokine and biomarkers(CRP、TNF-α、IL-6、IL-10、MCP-1) are examined by Elisa, circulating stem cell levels, immune cells subgroup ,platelet activation related markers CD62P、CD63 , number of megakaryocyte are evaluated by flow cytometry, infectious rate, mortality, incidence of multiple drug-resistant bacteria ,clinical complications: sepsis, bronchopulmonary dysplasia(BPD), retinopathy of prematurity (ROP), necrotising enterocolitis (NEC), intraventricular haemorrhage (IVH), anaemia before hospital discharge

  7. Long-term follow up: in 1m, 3m, 6m,1y: neurodevelopment [Bayley Scales of Infant], asthma, anemia and physique growth .
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Infection, Bacteroides
  • Neonates Premature
  • Neonatal Death
Intervention  ICMJE
  • Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
    Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of infection
  • Drug: 0.9% Sodium Chloride
    0.9% Sodium Chloride in control group
Study Arms  ICMJE
  • Experimental: CBMNC1
    Autologous Umbilical Cord Blood Mononuclear Cells Therapy 6 hours after birth ,dose is 25 million cells/kg ,the infusion speed is 4ml/kg/h, 8-12h,
    Intervention: Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
  • Experimental: CBMNC2
    Autologous Umbilical Cord Blood Mononuclear Cells Therapy 48 hours after birth ,dose is 25 million cells/kg ,the infusion speed is 4ml/kg/h, 8-12h,
    Intervention: Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
  • Placebo Comparator: Placebo1
    0.9% sodium chloride infusion 6 hours after birth ,the infusion speed is 4ml/kg/h, 8-12h,
    Intervention: Drug: 0.9% Sodium Chloride
  • Placebo Comparator: Placebo2
    0.9% sodium chloride infusion 48 hours after birth ,the infusion speed is 4ml/kg/h, 8-12h,
    Intervention: Drug: 0.9% Sodium Chloride
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 17, 2016)
320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2019
Estimated Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • twenty-eight weeks to thirty-seven weeks

Exclusion Criteria:

  • Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 28 Weeks to 36 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zhuxiao Ren, MD +8613538984634 renzhx1990@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02999373
Other Study ID Numbers  ICMJE Guangdong M And C
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party yangjie, Guangdong Women and Children Hospital
Study Sponsor  ICMJE Guangdong Women and Children Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jie Yang, PHD Guangdong Women and Children Hospital
PRS Account Guangdong Women and Children Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP