NCT04311476

Autologous Cord Blood Cells for Prevention of BPD in Preterm

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: yangjie · Academic / Other
• Sex: All
• Age: 28 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

Summary

To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates

Detailed description

We did a randomized, double-blind, placebo-controlled trial to assess effect of one intravenous dose of cord blood MNCs compared with placebo in reducing incidence of BPD in very preterm neonates.We enrolled preterm neonates less than 32 weeks of GA at neonatal intensive care units (NICUs) in Guangdong Women and Children Hospital within the first 24 postnatal hours. Patients were randomly assigned by 1:1 to receive either (5×107cells/kg ACBMNC or normal saline intravenously within 24 hours after birth according to a computer-generated schedule. The primary endpoint was efficacy at 36 GA or discharge home and all analyses were done by intention to prevent.MNCs viability was also tested before transfusion

Conditions

• Safety Issues
• BPD - Bronchopulmonary Dysplasia
• Neonatal Death

Interventions

Type	Name	Description
OTHER	Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy	Evaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
DRUG	0.9% Sodiun Chloride	0.9% Sodiun Chloride in control group

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2020-03-17
• Last updated: 2020-06-02

Locations

1 site across 1 country: China