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Effect of Autologous Cord Blood Mononuclear Cell in Preventing Complications of Monozygotic Twins in Very Premature Infants

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ClinicalTrials.gov Identifier: NCT05087498
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
yang jie, Guangdong Women and Children Hospital

Brief Summary:
This is a trial that evaluates the efficacy of autologous cord blood mononuclear cells infusion as a prevention therapy for complications of very premature infants. In this single-center clinical trial, 30 pairs of twins neonates less than 32 weeks are included. They are randomly divided into ACBMNC infusion group and (placebo) group. The primary outcome is the rate of complications at 36 weeks of postmenstrual age or discharge home. The secondary outcomes will include respiratory support duration, frequence of incubate, use of glucocorticoid, pulmonary surfactant and blood, duration of hospitalization and long term outcomes after two years follow up post infusion.

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

Detailed Description:

Study design and settings:

This study will be a randomized, placebo-controlled, double-blinded, single-center trial. A total of 30 pairs of monozygotic twins fulfilling the eligibility criteria will be enrolled. Subsequently, one baby of each twin will be randomly divided into the ACBMNC infusion group or control (placebo) group.

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 treatment. Those assigned to the ACBMNC group received an infusion of ACBMNC . Those in control group received an infusion of a placebo solution. Informed consent before birth is signed. Preterm infants in the ACBMNC infusion group will have their umbilical cord blood collected after birth, and then their umbilical cord blood will be separated through Guangdong Province umbilical cord blood Bank to obtain mesenchymal stem cells. Within 24h after birth, ACBMNC group received an infusion of mesenchymal stem cells timely, while control (placebo) 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 clinical trial, 30 pairs of monozygotic twins less than 32 weeks are enrolled, in which one of each twin is randomly assigned to receive intravenous autologous cord blood mononuclear cells infusion (5×107cells/kg) or placebo ( normal saline) within 24 hours after birth.
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 Cell in Preventing Complications of Monozygotic Twins in Very Premature Infants: a Placebo-controlled Randomized Single-center Trial
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : October 30, 2023

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 32 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 32 weeks are assigned to receive normal saline within 24 hours after birth




Primary Outcome Measures :
  1. Number of participants with complications according to their diagnostic criteria [ Time Frame: 36 weeks of postmenstrual age or discharge home whichever comes first. ]
    Collected number of participants with complications (e.g., 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) ) according to their diagnostic criteria at 36 weeks of postmenstrual age or discharge home whichever comes first, and then calculate their rate separately


Secondary Outcome Measures :
  1. Frequence of hospitalizations for pneumonia of each participants [ Time Frame: 1 year of postmenstrual age ]
    The frequence of hospitalizations for pneumonia at 1 year of postmenstrual age


Other Outcome Measures:
  1. Duration of mechanical ventilation, oxygen therapy and hospitalization [ Time Frame: 36 weeks of postmenstrual age or the discharge ]
    Duration of mechanical ventilation, oxygen therapy and hospitalization at 36 weeks of postmenstrual age or the discharge

  2. the frequence of glucocorticoid, pulmonary surfactant, blood products and re-intubation [ Time Frame: 36 weeks of postmenstrual age or the discharge ]
    the frequence of glucocorticoid, pulmonary surfactant, blood products and re-intubation at 36 weeks of postmenstrual age or the discharge



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Ages Eligible for Study:   0 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. born at study hospital;
  • 2. monozygotic twins less than 32 weeks GA.
  • 3.Signed informed consent obtained;
  • 4. available and qualified umbilical cord blood (UCB).

Exclusion Criteria:

  • 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): NCT05087498


Contacts
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Contact: Zhuxiao Ren, MD +8613538984634 renzhx1990@163.com
Contact: Jie Yang, PHD +86802039151600 jieyang0830@126.com

Locations
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China, Guangdong
Ren Xuejun Recruiting
Dongguan, Guangdong, China
Contact: Ren Xuejun, MD         
Jie Yang Recruiting
Guangzhou, Guangdong, China, 511400
Contact: Jie Yang, PHD    39151777 ext 020    jasjie_yang@163.com   
Sponsors and Collaborators
Guangdong Women and Children 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: NCT05087498    
Other Study ID Numbers: Guangdong M CH
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 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
monozygotic twins
very premature infants
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications