Effect of Autologous Cord Blood Mononuclear Cells for Prevention of Bronchopulmonary Dysplasia or Death in Extremely Preterm Neonates
1 other identifier
interventional
140
1 country
2
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 or death. 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, 140 extremely preterm neonates less than 28 weeks are randomly assigned to receive intravenous autologous cord blood mononuclear cells infusion (targeted dose of 5×107cells/kg but no less than 1×107cells/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, BPD severity, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2020
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2020
CompletedStudy Start
First participant enrolled
June 20, 2020
CompletedFirst Posted
Study publicly available on registry
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedNovember 1, 2023
October 1, 2023
3.5 years
June 18, 2020
October 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
frequency of bronchopulmonary dysplasia or death
The frequency of bronchopulmonary dysplasia or death at 36 weeks of postmenstrual age or discharge home whichever comes first.
36 weeks of postmenstrual age or discharge home whichever comes first.
Secondary Outcomes (1)
mortality
36 weeks of postmenstrual age or the discharge
Study Arms (2)
ACBMNC infusion group
EXPERIMENTALThose 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.
control group
PLACEBO COMPARATORThose in control group will receive an infusion of a placebo solution which is normal saline with the same volume.
Interventions
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
preterm neonates less than 28 weeks are assigned to receive normal saline within 24 hours after birth
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guangdong Women and Children Hospitallead
- Foshan Fuxing Chancheng Central Hospitalcollaborator
- Foshan Women's and Children's Hospitalcollaborator
- Hexian Memorial Affiliated Hospital of Southern Medical Universitycollaborator
- Heyuan Women and Children Hospitalcollaborator
- Dongguan Women and Children Hospitalcollaborator
- Guangzhou Huadu Women and Children Hospitalcollaborator
- Shunde Women and Children Hospitalcollaborator
- Guangdong Cord Blood Bankcollaborator
- Huangdu Distric Women and Children Hospitalcollaborator
- Longgang Distric Women and Children Hospital,Shenzhencollaborator
- BoAi Hospital of Zhongshancollaborator
- Huizhou first Women and Children Hospitalcollaborator
- Huizhou second Women and Children Hospitalcollaborator
Study Sites (2)
Ren Xuejun
Dongguan, Guangdong, China
Jie Yang
Guangzhou, Guangdong, 511442, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jie Yang
Guangdong Women and Children Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 22, 2020
Study Start
June 20, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
November 1, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- all time
- Access Criteria
- all
public