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Effect of Autologous Cord Blood Mononuclear Cells for Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Neonates

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ClinicalTrials.gov Identifier: NCT04440670
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : November 17, 2021
Sponsor:
Collaborators:
Foshan Chancheng Central Hospital
Foshan Women and Children Hospital
Hexian Memorial Affiliated Hospital of Southern Medical University
Heyuan Women and Children Hospital
Dongguan Women and Children Hospital
Guangzhou Huadu Women and Children Hospital
The fifth Affiliated Hospital of Guangzhou Medcial University
Guangdong Cord Blood Bank
Dongguang People Hospital
Information provided by (Responsible Party):
yang jie, Guangdong Women and Children Hospital

Brief Summary:
This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of autologous cord blood mononuclear cells infusion as a prevention therapy for BPD. The results of this trial will provide valuable clinical evidence for recommendations on the management of BPD in extremely preterm infants. In this prospective, randomized controlled double-blind multi-center clinical trial, 200 preterm neonates less than 28 weeks are randomly assigned to receive intravenous autologous cord blood mononuclear cells infusion (5×107cells/kg) or placebo ( normal saline) within 24 hours after birth in a 1:1 ratio using a central randomization system. The primary outcome is survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age or discharge home. The secondary outcomes will include mortality rate, other common preterm complication rate, respiratory support duration, the length and cost of hospitalization and long term outcomes after two years follow up post infusion.

Condition or disease Intervention/treatment Phase
BPD Biological: autologous cord blood mononuclear cells Biological: normal saline Phase 3

Detailed Description:

Study design and settings:

This present study will be a randomized, placebo-controlled, double-blinded, multi-center trial to be conducted at 14 medical centers in tertiary hospitals with Neonatal Intensive Care Unit that were selected by the expert committee. A total of 200 neonates fulfilling the eligibility criteria will be enrolled. Subsequently, the participants will be randomly divided into two groups (ACBMNC infusion group and control (placebo) group ) in a ratio of 1:1.

Objectives:

Primary objective: The primary objective of this trial is to evaluate the efficacy of ACBMNC infusion in preventing bronchopulmonary dysplasia at 36 weeks of postmenstrual age or discharge home in extremely preterm infants.

Secondary objectives:

  • To compare the mortality rate at 36 weeks of postmenstrual age.
  • To compare the rate of other common preterm complications included intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), respiratory distress syndrome (RDS), ventilation-associated pneumonia (VAP), hypoxic ischemic encephalopathy (HIE), late onset sepsis (LOS) and anemia.To compare the duration of mechanical ventilation and oxygen therapy in two groups
  • To determine re-intubation rate and time return to BW
  • To compare the duration of antibiotic usage
  • To determine the long term outcomes after two years follow up

Participants:

Inclusion criteria:

Infants fulfilling all the following inclusion criteria will be enrolled in this trial: 1. born at study hospital; 2. singleton birth; 3. less than 28 weeks GA 4.Signed informed consent obtained; 5. had available umbilical cord blood (UCB).

Exclusion criteria:

Those infants are excluded if they were 1. with severe congenital abnormalities; 2.with maternal clinical chorioamnionitis 3. the mother was positive for hepatitis B (HBsAg and/or HBeAg) or C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) or IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.

Trial treatment methods:

Soon after the preterm infant was deliveried, written consent was signed by the parents, and autologous cord blood infusion was applied to the baby in addition to routine pulmonary surfactant replacement, and mechanical ventilation support as indicated. Those assigned to the ACBMNC group received an infusion of ACBMNC with 24 h after birth. Those in control group received an infusion of a placebo solution which is normal saline with the same volume. Cell dose for all patients was targeted at 5×107 cells per kilogram.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this prospective, randomized controlled double-blind multi-center clinical trial, 200 preterm neonates less than 28 weeks are randomly assigned to receive intravenous autologous cord blood mononuclear cells infusion (5×107cells/kg) or placebo ( normal saline) within 24 hours after birth in a 1:1 ratio using a central randomization system.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: A hospital ethics committee reviewed the study data during the trials. None of them were involved in the study or aware of the treatment-group assignments of the infants. Only nurses and physicians staff conducted the infusion were aware of the treatment assignment, and these individuals had no contact with the staff who collected and analyzed the patients data. The parents are not aware of the assignment. This study is double-blinded.
Primary Purpose: Prevention
Official Title: Effect of Autologous Cord Blood Mononuclear Cells for Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Neonates: a Placebo-controlled Randomized Multicenter Trial
Actual Study Start Date : June 20, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACBMNC infusion group
Those assigned to the ACBMNC group will receive intravenous autologous cord blood mononuclear cells infusion within 24 h after birth. Cell dose for all patients was targeted at 5×107 cells per kilogram.
Biological: autologous cord blood mononuclear cells
preterm neonates less than 28 weeks are assigned to receive intravenous autologous cord blood mononuclear cells infusion (5×107cells/kg) within 24 hours after birth

Placebo Comparator: control group
Those in control group will receive an infusion of a placebo solution which is normal saline with the same volume.
Biological: normal saline
preterm neonates less than 28 weeks are assigned to receive normal saline within 24 hours after birth




Primary Outcome Measures :
  1. frequency of bronchopulmonary dysplasia [ Time Frame: 36 weeks of postmenstrual age or discharge home whichever comes first. ]
    The frequency of bronchopulmonary dysplasia at 36 weeks of postmenstrual age or discharge home whichever comes first.


Secondary Outcome Measures :
  1. mortality [ Time Frame: 36 weeks of postmenstrual age or the discharge ]

    The mortality rate.

    • Incidence of other preterm complications including intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), respiratory distress syndrome (RDS), ventilation-associated pneumonia (VAP), late onset sepsis (LOS) and anemia .
    • Duration of hospitalization.
    • Duration of mechanical ventilation and oxygen therapy
    • The frequency of re-intubation.
    • The time (days) return to BW.



Information from the National Library of Medicine

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Ages Eligible for Study:   0 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Infants fulfilling all the following inclusion criteria will be enrolled in this trial: 1. born at study hospital; 2. singleton birth; 3. less than 28 weeks GA 4.Signed informed consent obtained; 5. had available umbilical cord blood (UCB).

Exclusion Criteria:

Those infants are excluded if they were 1. with severe congenital abnormalities; 2.with maternal clinical chorioamnionitis 3. the mother was positive for hepatitis B (HBsAg and/or HBeAg) or C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) or IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.


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): NCT04440670


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

Locations
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China, Guangdong
Ren Xuejun Recruiting
Dongguan, Guangdong, China
Contact: Ren Xuejun, MD         
Jie Yang Recruiting
Guangzhou, Guangdong, China, 511442
Contact: Jie Yang, PHD    39151777 ext 020    jieyang@126.com   
Sponsors and Collaborators
Guangdong Women and Children Hospital
Foshan Chancheng Central Hospital
Foshan Women and Children Hospital
Hexian Memorial Affiliated Hospital of Southern Medical University
Heyuan Women and Children Hospital
Dongguan Women and Children Hospital
Guangzhou Huadu Women and Children Hospital
The fifth Affiliated Hospital of Guangzhou Medcial University
Guangdong Cord Blood Bank
Dongguang People Hospital
Investigators
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Study Chair: Jie Yang Guangdong Women and Children Hospital
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Responsible Party: yang jie, Professor, Guangdong Women and Children Hospital
ClinicalTrials.gov Identifier: NCT04440670    
Other Study ID Numbers: Guang dong W C H
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: public
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: all time
Access Criteria: all

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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 yang jie, Guangdong Women and Children Hospital:
Autologous cord blood mononuclear cells
bronchopulmonary dysplasia
extremely preterm neonates
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases