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

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.

Conditions

• BPD

Interventions

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

BIOLOGICAL

normal saline

preterm neonates less than 28 weeks are assigned to receive normal saline within 24 hours after birth

Sponsors & Collaborators

• Foshan Fuxing Chancheng Central Hospital

  collaborator UNKNOWN

• Foshan Women's and Children's Hospital

  collaborator OTHER

• Hexian Memorial Affiliated Hospital of Southern Medical University

  collaborator UNKNOWN

• Heyuan Women and Children Hospital

  collaborator UNKNOWN

• Dongguan Women and Children Hospital

  collaborator UNKNOWN

• Guangzhou Huadu Women and Children Hospital

  collaborator UNKNOWN

• Shunde Women and Children Hospital

  collaborator UNKNOWN

• Guangdong Cord Blood Bank

  collaborator INDUSTRY

• Huangdu Distric Women and Children Hospital

  collaborator UNKNOWN

• Longgang Distric Women and Children Hospital,Shenzhen

  collaborator UNKNOWN

• BoAi Hospital of Zhongshan

  collaborator OTHER

• Huizhou first Women and Children Hospital

  collaborator UNKNOWN

• Huizhou second Women and Children Hospital

  collaborator UNKNOWN

• Guangdong Women and Children Hospital

  lead OTHER

Principal Investigators

• Jie Yang · Guangdong Women and Children Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

0 Weeks

Max Age

28 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-20

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• China

Study Locations