Autologous Cord Blood Cells for Prevention of BPD in Preterm

Safety Issues Clinical Trial

Official title:

Autologous Cord Blood Cells for Prevention of BPD in Preterm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04311476
• Other study ID #: Guangdong WC H
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: May 2020
• Source: Guangdong Women and Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 32 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• BPD - Bronchopulmonary Dysplasia
• Bronchopulmonary Dysplasia
• Neonatal Death
• Perinatal Death
• Safety Issues

Intervention

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

Locations

Country	Name	City	State
China	Jie Yang	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
yangjie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients without bronchopulmonary dysplasia	bronchopulmonary dysplasia incidence	at 36 weeks of postmenstrual age or discharge home, whichever came first
Secondary	number of patients who died, severe bronchopulmonary dysplasia	mortaliity rate	at 36 weeks of postmenstrual age