Autologous Cord Blood Cells for Prevention of BPD in Preterm

NCT04311476 | Completed Phase 2

• 1 other identifier: Guangdong WC H
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety Issues; BPD - Bronchopulmonary Dysplasia; Neonatal Death

Keywords

ACBMNC; very premature infants; BPD

Outcome Measures

Primary Outcomes (1)

• number of patients without bronchopulmonary dysplasia

  bronchopulmonary dysplasia incidence

  at 36 weeks of postmenstrual age or discharge home, whichever came first

Secondary Outcomes (1)

• number of patients who died， severe bronchopulmonary dysplasia

  at 36 weeks of postmenstrual age

Study Arms (2)

Placebo

PLACEBO COMPARATOR

0.9% sodium chloride infusion within 24 hours after birth

Drug: 0.9% Sodiun Chloride

ACBMNC

EXPERIMENTAL

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

Interventions

Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy OTHER

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

Also known as: Autologous Umbilical Cord Blood Mononuclear Cells Therapy

ACBMNC

0.9% Sodiun Chloride DRUG

0.9% Sodiun Chloride in control group

Placebo

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• yangjie: lead

Study Sites (1)

Jie Yang

Guangzhou, Guangdong, 511442, China

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Perinatal Death

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jie Yang, PHD

  Guangdong Women and Children Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Dept of Neonatology

Study Record Dates

• First Submitted: March 15, 2020
• First Posted: March 17, 2020
• Study Start: July 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)