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Autologous Cord Blood Cells for Prevention of BPD in Preterm

Primary Purpose

Safety Issues, BPD - Bronchopulmonary Dysplasia, Neonatal Death

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy
0.9% Sodiun Chloride
Sponsored by
yangjie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Safety Issues focused on measuring ACBMNC, very premature infants, BPD

Eligibility Criteria

28 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jie Yang

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

ACBMNC

Arm Description

0.9% sodium chloride infusion within 24 hours after birth

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

Outcomes

Primary Outcome Measures

number of patients without bronchopulmonary dysplasia
bronchopulmonary dysplasia incidence

Secondary Outcome Measures

number of patients who died， severe bronchopulmonary dysplasia
mortaliity rate

Full Information

First Posted
March 15, 2020
Last Updated
May 29, 2020
Sponsor
yangjie
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1. Study Identification

Unique Protocol Identification Number
NCT04311476
Brief Title
Autologous Cord Blood Cells for Prevention of BPD in Preterm
Official Title
Autologous Cord Blood Cells for Prevention of BPD in Preterm
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
yangjie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues, BPD - Bronchopulmonary Dysplasia, Neonatal Death
Keywords
ACBMNC, very premature infants, BPD

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride infusion within 24 hours after birth
Arm Title
ACBMNC
Arm Type
Experimental
Arm Description
Autologous Umbilical Cord Blood Mononuclear Cells intravenously within 24 hours after birth,dose is 5×107cells/kg ,
Intervention Type
Other
Intervention Name(s)
Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy
Other Intervention Name(s)
Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Intervention Description
Evaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
Intervention Type
Drug
Intervention Name(s)
0.9% Sodiun Chloride
Intervention Description
0.9% Sodiun Chloride in control group
Primary Outcome Measure Information:
Title
number of patients without bronchopulmonary dysplasia
Description
bronchopulmonary dysplasia incidence
Time Frame
at 36 weeks of postmenstrual age or discharge home, whichever came first
Secondary Outcome Measure Information:
Title
number of patients who died， severe bronchopulmonary dysplasia
Description
mortaliity rate
Time Frame
at 36 weeks of postmenstrual age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Yang, PHD
Organizational Affiliation
Guangdong Women and Children Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jie Yang
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
511442
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Autologous Cord Blood Cells for Prevention of BPD in Preterm

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