Autologous Cord Blood Cells for Prevention of BPD in Preterm

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

Study Overview

• Status: Completed
• Conditions: Safety Issues; Neonatal Death; BPD - Bronchopulmonary Dysplasia
• Intervention / Treatment: Drug: 0.9% Sodiun Chloride; Other: Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy

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

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 511442
      • Jie Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 0.9% sodium chloride infusion within 24 hours after birth	Drug: 0.9% Sodiun Chloride; 0.9% Sodiun Chloride in control group
Experimental: ACBMNC; Autologous Umbilical Cord Blood Mononuclear Cells intravenously within 24 hours after birth,dose is 5×107cells/kg ,	Other: Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy; Evaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates; Other Names: Autologous Umbilical Cord Blood Mononuclear Cells Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients without bronchopulmonary dysplasia	bronchopulmonary dysplasia incidence	at 36 weeks of postmenstrual age or discharge home, whichever came first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients who died， severe bronchopulmonary dysplasia	mortaliity rate	at 36 weeks of postmenstrual age

Collaborators and Investigators

• Sponsor: yangjie
• Investigators: Principal Investigator: Jie Yang, PHD, Guangdong Women and Children Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: March 15, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: BPD; very premature infants; ACBMNC
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Death; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia; Perinatal Death
• Other Study ID Numbers: Guangdong WC H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No