Autologous Cord Blood Cells for Prevention of BPD in Preterm

Phase 2

Completed

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

• Registration Number: NCT04311476
• Lead Sponsor: yangjie

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

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Study First Submitted: 2020-03-15
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-17
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-29
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	0.9% Sodiun Chloride	0.9% sodium chloride infusion within 24 hours after birth
ACBMNC	Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy	Autologous Umbilical Cord Blood Mononuclear Cells intravenously within 24 hours after birth,dose is 5×107cells/kg ,

Primary Outcome Measures

Name	Time	Method
number of patients without bronchopulmonary dysplasia	at 36 weeks of postmenstrual age or discharge home, whichever came first	bronchopulmonary dysplasia incidence

Secondary Outcome Measures

Name	Time	Method
number of patients who died， severe bronchopulmonary dysplasia	at 36 weeks of postmenstrual age	mortaliity rate

Trial Locations

Locations (1)

Jie Yang; 🇨🇳 Guangzhou, Guangdong, China