Autologous Cord Blood Cells for Prevention of BPD in Preterm

NCT ID: NCT04311476

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-01-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Placebo

0.9% sodium chloride infusion within 24 hours after birth

Group Type: PLACEBO_COMPARATOR

0.9% Sodiun Chloride

Intervention Type: DRUG

0.9% Sodiun Chloride in control group

ACBMNC

Autologous Umbilical Cord Blood Mononuclear Cells intravenously within 24 hours after birth,dose is 5×107cells/kg ,

Group Type: EXPERIMENTAL

Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy

Intervention Type: OTHER

Evaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates

Interventions

Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy

Evaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates

Intervention Type: OTHER

0.9% Sodiun Chloride

0.9% Sodiun Chloride in control group

Intervention Type: DRUG

Other Intervention Names

Autologous Umbilical Cord Blood Mononuclear Cells Therapy

Eligibility Criteria

Inclusion Criteria

• born in the study hospital;
• singleton birth;
• less than 32 weeks GA
• Without congenital malformations or known chromosomal aberrations;
• Without clinical chorioamnionitis;
• the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus;
• consents were obtained from their parents or guardians;
• the umbilical cord blood cells after processing were available.

Exclusion Criteria

• birth-weight was less than the third percentile for gestational age according to Fenton curve,
• if they had severe perinatal asphyxia (defined as an Apgarscore of 0-3 for more than 5 minutes, a cord blood pH of less than 7.00, or both) and were expected to die shortly after birth.

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

yangjie

OTHER

Sponsor Role: lead

Responsible Party

yangjie

Director of Dept of Neonatology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jie Yang, PHD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Women and Children Hospital

Locations

Jie Yang

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

Guangdong WC H

Identifier Type: -

Identifier Source: org_study_id